FDA pediatric study reviews, BPCA and PREA, 2012–present
Summary
FDA pediatric study reviews, BPCA and PREA, 2012–present
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GovPing monitors FDA Recent Drug Approvals for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 10 changes logged to date.
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Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
As required by 505A(k)(1) and 505B(h)(1) of the Federal Food, Drug, & Cosmetic Act (BPCA and PREA, respectively), the following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under PREA.
Total Number of Products Studied under BPCA = 88
Total Number of Products assessed under PREA = 549
Total Number of Products Studied or assessed under Both = 83
Find Reviews of Pediatric Studies Conducted under BPCA from 2002 – 2007
Find Biologics PREA Reviews and Labeling Changes
| Drug Sponsor | Sponsor | Medical Review | Clinical Pharmacology Review | Statistical Review | BPCA or PREA or Both |
|---|---|---|---|---|---|
| Abametapir - Xeglyze | Hatchtech Pty Ltd | Medical (PDF - 4 MB) |
Addendum (PDF - 78 KB)
CDTL (PDF - 3 MB)
Resubmission (PDF - 77 KB)
DD (PDF - 2 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 207 KB) | PREA |
| Abacavir and Lamivudine - Epzicom | ViiV Healthcare Company | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 158 KB) | Statistical (PDF - 693 KB) | PREA |
| Abacavir and lamivudine - None | Mylan Laboratories Limited, a Viatris Company | Medical (PDF - 211 KB) | None | None | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq | ViiV Healthcare Company | Medical (PDF - 443 KB) | Clinical pharmacology (PDF - 128 KB) | None | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq | ViiV Healthcare Company c/o GlaxoSmithKline | Medical (PDF - 389 KB)
CDTL (PDF - 798 KB) | Clinical pharmacology (PDF - 128 KB) | None | PREA |
| Abacavir, Dolutegravir, and Lamivudine - Triumeq PD | ViiV Healthcare Company | CDTL (PDF - 758 KB) | Clinical pharmacology (PDF - 3 MB) | None | BOTH |
| Abacavir sulfate - Ziagen | ViiV Healthcare Company | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 5 MB) | PREA |
| Abatacept - Orencia | Bristol-Myers Squibb Company | Medical (PDF - 259 KB)
Medical Addendum (PDF - 469 KB) | Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 269 KB) | None | BOTH |
| Abatacept - Orencia | Bristol-Myers Squibb Company | Medical (PDF - 4 MB) | None | None | BPCA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | CDTL Review (PDF - 2 MB)
Medical (PDF - 3 MB) | None | Statistical (PDF - 2 MB) | PREA |
| AbobotulinumtoxinA - Dysport | Ipsen Bipharm Limited | Medical (PDF - 1 MB) | None | Statistical (PDF - 857 KB) | PREA |
| Abrocitinib - Cibinqo | Pfizer Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Abrocitinib - Cibinqo | Pfizer Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Acetaminophen - Ofirmev | MallInc.krodt, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 378 KB) | BOTH |
| Acetylcysteine - Legubeti | Galephar Pharmaceutical Research Inc. | Unireview (PDF - 6 MB)
Unireview CR (PDF - 10 MB) | None | None | PREA |
| Acyclovir 5%, hydrocortisone 1% - Xerese | Valeant International Bermuda | Medical (PDF - 885 KB) | None | None | PREA |
| Adalimumab-adaz - Hyrimoz | Sandoz Inc. | Medical (PDF - 2 MB)
CDTL Review (PDF - 300 MB) | None | None | PREA |
| Adalimumab-adaz - Hyrimoz | Sandoz Inc. | CDTL Review (PDF - 342 KB) | None | None | PREA |
| Adalimumab-adaz - Hyrimoz | Sandoz Inc. | CDTL Review (PDF - 34 KB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | CDTL (PDF - 34 KB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Adalimumab-afzb - Abrilada | Pfizer Inc. | CDTL (PDF - 34 KB) | None | None | PREA |
| Adalimumab-aqvh - Yusimry | Coherus BioSciences, Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Adalimumab-aqvh - Yusimry | Coherus BioSciences, Inc | CDTL Review (PDF - 342 KB) | Clinical pharmacology (PDF - 22 KB) | None | PREA |
| adalimumab-aaty - Yuflyma | Celltrion, Inc. | CDTL Review (PDF - 342 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen Inc. | CDTL Review (PDF - 4 MB)
Medical (PDF - 199K KB)
Medical (PDF - 336KB)
DD Summary Review (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 416 KB)
Statistical (PDF - 363 KB)
Statistical (PDF - 717 KB) | PREA |
| Adalimumab-aaty - Yuflyma | Celltrion, Inc. | CDTL - DD (PDF - 356 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Adalimumab-atto - Amjevita | Amgen, Inc | CDTL (PDF - 580 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen, Inc | Medical (PDF - 532 KB) | None | None | PREA |
| Adalimumab-atto - Amjevita | Amgen, Inc | Medical (PDF - 532 KB) | None | None | PREA |
| Adalimumab-bwwd - Hadlima | Samsung Bioepis Co., Ltd. | Medical (PDF - 34 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Adalimumab-bwwd - Hadlima | Samsung Bioepis Co., Ltd. | Medical (PDF - 34 KB) | None | None | PREA |
| Adalimumab-bwwd - Hadlima | Samsung Bioepis Co., Ltd | Medical (PDF - 34 KB) | None | None | PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | Medical (PDF - 580 KB) | None | None | PREA |
| Adalimumab-fkjp - Hulio | Mylan Pharmaceuticals Inc. | CDTL (PDF - 24 KB) | None | None | PREA |
| Adalimumab - Humira | AbbVie,Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Adalimumab-aacf - Idacio | Fresenius Kabi USA, LLC | Medical (PDF - 20 MB) | None | None | PREA |
| Adalimumab-aacf - Idacio | Fresenius Kabi USA, LLC | Medical (PDF - 20 MB) | None | None | PREA |
| Adalimumab-ryvk - Simlandi | Alvotech USA Inc | Medical (PDF - 724 KB) | None | None | PREA |
| Adapalene and benzoyl peroxide - Epiduo | Galderma Laboratories, LP | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -124 KB) | Statistical (PDF - 577 KB) | PREA |
| Adapalene and benzoyl peroxide - Epiduo Forte | Galderma Research and Development LLC | Medical (PDF - 6.2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Afatini - Gilotrif | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | BPCA |
| Aflibercept-boav - Eydenzelt | CELLTRION, Inc. | CDTL1 (PDF - 1 MB)
CDTL2 (PDF - 3 MB)
CDTL3 (PDF - 976 KB) | None | None | PREA |
| Aflibercept - Eylea | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 5 MB) | BPCA |
| Anidulafungin - Eraxis | Vicuron Holdings LLC, a subsidiary of Pfizer Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Albuterol and Budesonide - Airsupra | Bond Avillion 2 Development LP | Medical (PDF - 12 MB) | None | None | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Pharmaceutical Products R. & D., Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Albuterol sulfate - ProAir RespiClick | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 859 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Alirocumab - Praluent | Regeneron Pharmaceuticals, Inc | Medical (PDF - 859 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Aliskiren - Tekturna | Noden Pharma DAC | CDTL (PDF - 310 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 442 KB) | BOTH |
| Alogliptin - Nesina | Takeda Pharmaceuticals U.S.A., Inc | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 937 KB) | Statistical (PDF - 536 KB) | PREA |
| Alogliptin and metformin - Kazano | Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 937 KB) | Statistical (PDF - 536 KB) | PREA |
| Amlodipine benzoate - Katerzia | Silvergate Pharmaceuticals, Inc | Medical (PDF - 46 KB) | Clinical pharmacology (PDF - 337 KB) | None | PREA |
| Amlodipine - Sdamlo | Brillian Pharma Inc. | CDTL - DD (PDF - 578 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Amphetamine - Adzenys ER | Neos Therapeutics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 4 KB) | None | PREA |
| Amphetamine Extended-Release Orally Disintegrating Tablets - Adzenys XR-ODT | Neos Therapeutics, Inc. | Medical (PDF - 470 KB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 767 KB) | PREA |
| Amphetamine - Dyanavel XR | Tris Pharma | Medical (PDF - 848 KB)
CDTL Review (PDF - 1 MB) | None | None | PREA |
| Amphetamine sulfate - Evekeo | Arbor Pharmaceuticals, LLC | Medical (PDF - 1 MB)
Medical (PDF - 155 KB) | Clinical pharmacology (PDF - 9 KB)
Clinical pharmacology memo (PDF - 9 KB) | Statistical (PDF - 532 KB) | PREA |
| Apixaban - Eliquis | Bristol-Myers Squibb Company | Medical (PDF - 6 MB) | None | None | PREA |
| Apremilast - Otezla | Amgen, Inc | Medical (PDF - 7 MB) | None | None | BOTH |
| Apremilast - Otezla | Amgen, Inc | Medical (PDF - 7 MB) | None | None | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 6 MB)
Medical Addendum (PDF - 1 MB)
Medical DD memo (PDF - 3 MB) | Clinical pharmacology (PDF - 5 MB)
Clinical pharmacology addendum (PDF - 424 KB) | Statistical (PDF - 1 MB) | PREA |
| Aprepitant - Emend | Merck Sharp & Dohme Corp. | Medical (PDF - 553 KB) | Clinical pharmacology (PDF - 5 MB)
Addendum (PDF -105 KB) | Statistical (PDF - 1 MB) | PREA |
| Aripiprazole - Abilify | Otsuka | Medical (PDF - 2 MB) | None | Statistical (PDF - 409 KB) | PREA |
| Aripiprazole - Mezofy | CMG Pharmaceutical Co., Ltd | CDTL (PDF - 251 KB)
Medical (PDF - 1 MB) | None | None | PREA |
| Aripiprazole - Opipza | Xiamen LP Pharmaceutical Co., Ltd. | Medical (PDF - 2 MB) | None | None | PREA |
| Articaine ophthalmic solution - Cyklx | American Genomics, LLC | Medical (PDF - 453 KB)
CDTL-DD (PDF - 1 MB) | Clinical pharmacology (PDF - 519 KB) | Statistical (PDF - 767 KB) | PREA |
| Asenapine - Saphris | Forest Laboratories, Inc. | Medical (PDF - 5 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 3 MB) | BOTH |
| Asparaginase erwinia chrysanthemi (recombinant)- rywn - Rylaze | Jazz Pharmaceuticals Ireland Limited | Medical (PDF - 4 MB) | None | None | PREA |
| Atazanavir and cobicistat - Evotaz | Bristol-Myers Squibb Company | CDTL (PDF - 402 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 14 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | BOTH |
| Atazanavir - Reyataz | Bristol-Myers Squibb Company | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 4 MB) | BOTH |
| Atezolizumab - TECENTRIQ | Genentech, Inc. | Medical (PDF - 1 MB) | None | None | BPCA |
| Atezolizumab - Tecentriq | Genentech, Inc. | Medical (PDF - 3 MB) | None | None | BPCA |
| Atorvastatin calcium - Atorvaliq | CMP Development LLC | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Atropine-pralidoxime - DueDote | Meridian Medical Technologies, Inc. | CDTL (PDF - 402 KB)
Medical (PDF - 886 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Atropine Sulfate - Isopto Atropine 1% | Alcon Research, Ltd. | Medical (PDF - 663 KB) | Clinical pharmacology (PDF - 480KB) | Statistical (PDF - 230 KB) | PREA |
| Atropine Sulfate Ophthalmic Solution | Akorn, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 287 KB) | PREA |
| Axitinib - Inlyta | PF PRISM C.V. | Medical (PDF - 849 KB) | Clinical pharmacology (PDF - 2 MB) | None | BOTH |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals | Clinical (PDF - 1 MB) | None | Statistical (PDF - 473 KB | PREA |
| Azelastine hydrochloride - Astepro | Meda Pharmaceuticals Inc. | Medical (PDF - 2 MB) | None | None | BOTH |
| Azelastine hydrochloride and Fluticasone propionate - Dymista | Meda Pharmaceuticals, Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF - 2 MB) | BOTH |
| Baclofen - Fleqsuvy | Azurity Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 367 KB) | None | PREA |
| Baclofen - Lyvispah | Saol Therapeutics Research Limited | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 448 KB) | None | PREA |
| Baloxavir marboxil - Xofluza | Shionogi, Incorporated | CDTL (PDF - 869 KB)
Medical (PDF - 414 KB) | Clinical pharmacolog y (PDF - 3 MB) | Statistica l (PDF - 2 MB) | PREA |
| Baloxavir marboxil - Xofluza | Genentech, Incorporated | CDTL (PDF - 853 KB)
Medical (PDF - 6 MB KB) | Clinical pharmacology (PDF - 420 KB) | None | PREA |
| Baloxavir marboxil - Xofluza | Genentech, Incorporated | Medical (PDF - 248 KB) | None | None | PREA |
| Barium sulfate - E-Z-DISK | Bracco Diagnostics Inc. | Medical (PDF - 12 KB)
DD Summary Review (PDF - 233 57 KB) | None | None | PREA |
| Barium sulfate - E-Z-HD | Bracco Diagnostics Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -642KB) | Statistical (PDF -988KB) | PREA |
| Barium sulfate - READI-CAT 2 & READI-CAT 2 SMOOTHIE | Bracco Diagnostics | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 702 KB) | Statistical (PDF -1 MB) | PREA |
| Barium sulfate - Varibar Pudding | Bracco Diagnostics, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Barium sulfate - Liquid E-Z-Paque | Bracco Diagnostics, Inc. | DD Summary Review (PDF - 233 KB) | None | None | PREA |
| Beclomethasone dipropionate - Qnasl | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF -959 KB) | PREA |
| Belimumab - Benlysta | GlaxoSmithKline (GSK) LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Belimumab - Benlysta | GlaxoSmithKline (GSK) LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Belumosudil - Rezurock | Kadmon Pharmaceuticals, LLC | Medical (PDF - 7 MB) | None | None | PREA |
| Belimumab - Benlysta | Human Genome Sciences | Medical (PDF - 6 MB) | None | None | PREA |
| Belimumab - Benlysta | GlaxoSmithKline LLC | Medical (PDF - 7 MB) | None | None | PREA |
| Belzutifan - Welireg | Merck Sharpe & Dohme LLC | Medical (PDF - 12 MB) | None | None | PREA |
| Benralizumab - Fasenra | AstraZeneca AB | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 2 MB) | PREA |
| Benralizumab - Fasenra | AstraZeneca AB c/o AstraZeneca Pharmaceuticals LP | Medical (PDF - 7 MB)
Unireview (PDF - 11 KB) | None | None | PREA |
| Berdazimer - Zelsuvmi | LNHC, Inc. | Medical (PDF - 12 MB) | None | None | PREA |
| Berotralstat - Orladeyo | BioCryst Pharmaceuticals, Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Bezlotoxumab - Zinplava | Merck Sharp & Dohme Corp. | Medical (PDF - 2 MB) | None | None | BOTH |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. | CDTL (PDF - 157 KB)
CDTL 1 (PDF - 2 MB) | Clinical pharmacology (PDF - 2 MB) | None | BOTH |
| Bictegravir, emtricitabine, and tenofovir alafenamide - Biktarvy | Gilead Sciences, Inc. | CDTL (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | None | BOTH |
| Bimatoprost ophthalmic solution, 0.03% - Latisse | Allergan, Inc. | DD Summary Review (PDF - 966KB)
CDTL Review (PDF - 3 MB)
Medical (PDF - 2 MB) | None | Statistical (PDF -946KB)
Statistical Addendum (PDF - 127KB) | PREA |
| Blinatumomab - Blincyto | Amgen, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF -1 MB) | Statistical (PDF - 374 KB) | BPCA |
| Blinatumomab - Blincyto | Amgen, Inc. | Medical (PDF - 9 MB) | None | None | BPCA |
| Bortezomib - Velcade | Millennium Pharmaceuticals, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 374 KB) | BPCA |
| Bosutinib - BOSULIF | PF Prism C.V | Medical (PDF - 10 MB) | None | None | BPCA |
| Budesonide - Entocort EC | Elan Pharma International | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Brensocatib - Brinsupri | Insmed Incorporated | Medical (PDF - 21 MB) | None | None | PREA |
| Brentuximab vedotin - Adcetris | Seagen Inc. | Medical (PDF - 1 MB) | None | None | BPCA |
| Brexanolone - Zulresso | Sage Therapeutics, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Brexpiprazole - Rexulti | Otsuka Pharmaceutical Company, Ltd. | Medical (PDF - 4 MB) | None | None | PREA |
| Brexpiprazole - Rexulti | Otsuka Pharmaceutical Company, Ltd. C/O Otsuka Pharmaceutical Development & Commercialization, Inc. | Medical (PDF - 3 MB) | None | None | BPCA |
| Brexpiprazole - Rexulti | Otsuka Pharmaceutical Company Ltd. | Medical (PDF - 3 MB) | None | None | PREA |
| Brimonidine tartrate - Lumify | Bausch + Lomb | CDTL Review (PDF - 3 MB)
Medical (PDF - 556 KB) | Clinical pharmacology (PDF - 51 KB) | Statistica l (PDF - 219 KB) | PREA |
| Brivaracetam - Briviact | UCB, Inc. | CDTL Review (PDF - 297 KB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Brivaracetam - Briviact | UCB, Inc. | Medical (PDF - 74 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Budesonide/formoterol fumarate dehydrate - Symbicort | AstraZeneca Pharmaceuticals, LP | Medical (PDF - 3.4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 3 MB) | BOTH |
| Bupivacaine - Exparel | Pacira Pharmaceuticals, Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Buprenorphine - Butrans | Purdue Pharma L.P. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Cabazitaxel - Jevtana | Sanofi-Aventis U.S., L.L.C. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Cabotegravir - Apretude | ViiV Healthcare Company | Medical (PDF - 8 MB) | None | None | PREA |
| Cabotegravir - Apretude | ViiV Healthcare Company | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Cabotegravir-rilpivirine - Cabenuva | ViiV Healthcare Company | Medical (PDF - 35 KB) | Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology Addendum (PDF - 229 KB) | None | PREA |
| Cabotegravir and rilpivirine - Cabenuva | ViiV Healthcare Company | Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 5 MB) | None | PREA |
| Cabotegravir - Vocabria | ViiV Healthcare Company | CDTL (PDF - 1 MB)
Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 2 MB)
Addendum (PDF - 115 KB) | None | PREA |
| Cabotegravir - Vocabria | ViiV Healthcare Company | Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 5 MB) | None | PREA |
| Cabozantinib - Cabometyx | Exelixis, Inc. | Medical (PDF - 9 MB) | None | None | PREA |
| Calcipotriene - SORILUX | Mayne Pharma LLC | Medical (PDF - 525 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF -6 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 564 KB) | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S c/o LEO Pharma, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Calcipotriene and Betamethasone dipropionate - Taclonex | LEO Pharma A/S | Medical (PDF - 775 KB) | Clinical pharmacology (PDF - 528 KB) | None | PREA |
| Calcipotriene and betamethasone - Enstilar | LEO Pharma A/S | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 458 KB) | None | BOTH |
| Calcium Gluconate injection - Calcium Gluconate Injection | Fresenius Kabi USA, LLC | Medical (PDF - 4 MB)
Medical CTDL (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Calcipotriene - SORILUX Foam | Mayne Pharma LLC | Medical (PDF - 525 KB) | None | None | PREA |
| Calcitriol - Vectical | Galderma Laboratories, L.P. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Canagliflozin - Invokana | Janssen Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 828 KB) | BPCA |
| Canagliflozin and Metformin Hydrochloride - Invokamet | Janssen Pharmaceuticals, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 1 MB) | BPCA |
| Canagliflozin and metformin - Invokamet XR | Janssen Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 828 KB) | BPCA |
| Cantharidin - Ycanth | Verrica Pharmaceuticals Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Capecitabine - Xeloda | Hoffmann-La Roche, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 610 KB) | BPCA |
| Carbinoxamine maleate - Karbinal ER | Tris Pharma, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 500 KB) | None | PREA |
| Carfilzomib - Kyprolis | Onyx Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | BPCA |
| Cariprazine Vraylar | AbbVie Inc. | Medical (PDF - 5 MB) |
| Cefazolin sodium and dextrose solution - Cefazolin for Injection USP and Dextrose Injection USP in the Duplex® Container | B. Braun Medical Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Cefazolin in Dextrose Injection - Cefazolin in Dextrose Injection | Baxter Healthcare Corporation | Medical (PDF - 435 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Ceftaroline fosamil - Teflaro | Cerexa, Inc., A Subsidiary of Forest Laboratories, LLC | Medical (PDF - 11 MB)
Medical CTDL (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Ceftaroline fosamil - Teflaro | Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Ceftazidime and Avibactam - Avycaz | Allergan Sales, LLC | Medical (PDF - 5 MB) | None | None | PREA |
| Ceftazidime and avibactam - Avycaz | Allergan Sales, LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftazidime and avibactam - Avycaz | AbbVie, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftobiprole medocaril sodium for injection - Zevtera | Basilea Pharmaceutica International, Ltd., Allschwil | Medical (PDF - 4 MB) | None | None | PREA |
| Ceftolozane and tazobactam - Zerbaxa | Cubist Pharmaceuticals, LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Celecoxib - Vyscoxa | CodaDOSE, Inc. | Medical PDF - 26 KB) | Clinical pharmacology (PDF - 18 KB)
Clinical pharmacology addendum (PDF - 2 MB) | None | PREA |
| Cemiplimab-rwlc - Libtayo | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 26 KB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Certolizumab pegol - Cimzia | UCB, Inc | Medical (PDF - 4 MB) | None | None | PREA |
| Certolizumab pegol - Cimzia | UCB, Inc | Medical (PDF - 4 MB) | None | None | PREA |
| Cetirizine ophthalmic solution - Zerviate | Nicox Ophthalmics, Inc. | Medical Resubmission (PDF - 231 KB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 279 KB) | Statistical (PDF - 580 KB) | BOTH |
| Cetirizine hydrochloride - Quzyttir | JDP Therapeutics Inc | Medical (PDF - 2 MB) | None | None | PREA |
| Ciclesonide - Zetonna | Takeda GmbH | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 674 KB) | PREA |
| Cinacalcet hydrochloride - Sensipar | | CDTL (PDF - 2 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 957 KB) | BOTH |
| Ciprofloxacin 0.3% and Fluocinolone acetonide 0.025% - Otovel Otic Solution | Laboratorios SALVAT, S.A. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 632 KB) | Statistical (PDF - 2 MB) | PREA |
| Ciprofloxacin otic suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 233 KB) | Clinical pharmacology (PDF - 79 KB) | Statistical (PDF - 213 MB | PREA |
| 6% Ciprofloxacin Otic Suspension - Otiprio | Otonomy, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 97 KB) | Statistical (PDF - 896 KB)
Addendum (PDF - 157 KB | PREA |
| Ciprofloxacin ophthalmic solution - Ciloxan | Novartis Pharmaceuticals Corporation | Medical (PDF - 110 KB)
Medical (PDF - 173 KB) | None | None | BPCA |
| Clascoterone - Winlevi | Cassiopea SpA | Medical (PDF - 3 MB) | None | None | PREA |
| Clesrovimab-cfor - Enflonsia | Merck Sharp & Dohme LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Clindamycin phosphate, adapalene, and benzoyl peroxid - Cabtreo | Bausch Health US, LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Clindamycin phosphate - Xaciato | Daré Bioscience Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Clonidine hydrochloride extended-release oral suspension - Onyda XR | Tris Pharma, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Clonidine - Kapvay | Concordia Pharms Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF - 2 MB) | PREA |
| Cobicistat - Tybost | Gilead Sciences, Inc. | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Cobicistat - Tybost | Gilead Sciences, Inc. | CDTL (PDF - 4 MB) | None | None | PREA |
| Cobimetinib - Cotellic | Genentech, Inc. | Medical (PDF - 27 KB) | Clinical pharmacology (PDF - 543 KB) | None | BPCA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | CDTL (PDF - 2 MB)
Medical (PDF - 12 MB) | Clinical pharmacology (PDF - 7 MB) | None | PREA |
| Colesevelam HCl - Welchol | Daiichi Sankyo Inc. | Medical (PDF - 3 MB) | None | Statistical (PDF - 308 KB) | PREA |
| Crisaborole Ointment, 2% - Eucrisa | Anacor Pharmaceuticals Inc. | CDTL Review (PDF - 2 MB)
Medical (PDF - 12 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 1 MB) | PREA |
| Crisaborole - Eucrisa | Anacor Pharmaceuticals, LLC. | Medical (PDF - 2 MB) | None | None | PREA |
| Crisaborole - Eucrisa | Pfizer | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Cysteamine bitartrate - Procysbi | Raptor Pharmaceuticals, Inc. | Medical (PDF - 12 MB) | Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology addendum (PDF - 420 KB) | None | BPCA |
| Cysteamine bitartrate - Procysbi | Horizon Pharma USA, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | BPCA |
| Cysteamine hydrochloriden - CYSTADROPS | Recordati Rare Diseases Inc. | Medical (PDF - 294 KB) | None | None | PREA |
| Dabigatran etexilate - Pradaxa | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 2 MB)
Medical (PDF - 700 KB) | Clinical pharmacology (PDF - 5 MB) | None | BOTH |
| Dabrafenib - Tafinlar | Novartis Pharmaceuticals Corporation | Medical (PDF - 18 MB) | None | None | BPCA |
| Dabrafenib - Tafinlar | Novartis Pharmaceuticals Corporation | Medical (PDF - 10 MB)
CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 579 KB) | None | BPCA |
| Dalbavancin hydrochloride - Dalvance | Allergan Sales, LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Dalteparin sodium - Fragmin | Pharmacia & Upjohn, a subsidiary of Pfizer Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide - Symtuza | Jannsen | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Dapagliflozin - Farxiga | AstraZeneca AB C/O: AstraZeneca Pharmaceuticals LP | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | BPCA |
| Dapagliflozin and metformin hydrochloride - Xigduo XR | AstraZeneca AB C/O: AstraZeneca Pharmaceuticals LP | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | BPCA |
| Dapsone - Aczone | Allergan, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2.6 MB) | Statistical (PDF - 1 MB) | PREA |
| Dapsone - Aczone | Almirall, LLC | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 505 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 KB)
Statistical Addendum (PDF - 96 KB) | PREA |
| Daptomycin - Cubicin | Cubist Pharmaceuticals, LLC c/o Merck Sharp & Dohme Corp. | Medical (PDF - 389 KB) | Clinical pharmacology (PDF - 991 KB)
Clinical pharmacology Addendum (PDF - 80 KB) | Statistical (PDF - 374 KB) | PREA |
| Daptomycin - Dapzura RT | Baxter Healthcare Corporation | Medical (PDF - 2 MB) | None | None | PREA |
| Darbepoetin alfa - Aranesp | Amgen Inc. | Medical (PDF - 2 MB) | None | Statistical (PDF - 280 KB) | BPCA |
| Darunavir/Cobicistat - Prezcobix | Janssen Products, LP | Medical (PDF - 10 MB) | None | None | BOTH |
| Darunavir and Cobicistat - Prezcobix | Janssen Products, LP | Medical (PDF - 147 KB) | Clinical pharmacology (PDF - 20 KB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Darunavir - Prezista | Janssen Products, L.P. | None | Clinical pharmacology (PDF - 352 KB) | None | PREA |
| Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide - Symtuza | Janssen Products, L.P. | Multi-disciplinary review (PDF - 8 MB) | None | None | PREA |
| Dasatinib - Sprycel | Bristol-Myers Squibb Company | CDTL Review (PDF - 1 MB)
Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 531 KB) | Statistical (PDF - 19 KB) | BPCA |
| Dasiglucagon - Zegalogue | Zealand Pharma A/S | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 33 KB)
Clinical pharmacology Addendum (PDF - 38 KB) | Statistical (PDF - 2 MB) | PREA |
| Daunorubicin and cytarabine (liposome injection) - Vyxeos | Jazz Pharmaceuticals | Multidisciplinary (PDF - 5 MB) | None | None | BPCA |
| Daunorubicin and cytarabine - Vyxeos | Jazz Pharmaceuticals Therapeutics, Inc | Multidisciplinary (PDF - 5 MB) | None | None | BPCA |
| Decitabine - Dacogen | Eisai Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Deferasirox - Exjade | Novartis Pharmaceuticals Corporation | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | BPCA |
| Deferasirox - Exjade | Novartis Pharmaceuticals Corporation | CDTL Review (PDF - 795 KB)
Medical (PDF - 843 KB) | None | None | BPCA |
| Deferasirox - Jadenu | Novartis Pharmaceuticals Corporation | CDTL Review (PDF - 2 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Denosumab-bmwo - Osenvelt | Celltrion, Inc. | Medical (PDF - 9 MB) | None | None | PREA |
| Denosumab-bmwo - Stoboclo | Celltrion, Inc. | CDTL (PDF - 2 MB) | None | None | PREA |
| Denosumab-bnht - Conexxence | Fresenius Kabi USA, LLC | Medical (PDF - 1 MB)
Medical (PDF - 1 MB) | None | None | PREA |
| Denosumab-dssb - Ospomyv | Samsung Bioepis Co., Ltd. | Medical (PDF - 212 KB) | None | None | PREA |
| Denosumab-kyqq - Bosaya | Biocon Biologics Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Denosumab-nxxp - Bildyos | Shanghai Henlius Biotech, Inc | Medical (PDF - 4 MB) | None | None | PREA |
| Denosumab - Prolia | Amgen Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Denosumab-qbde - Enoby | Hikma Pharmaceuticals USA Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Depemokimab-ulaa - Exdensur | GlaxoSmithKline LLC | Medical (PDF - 16 MB) | None | None | PREA |
| Desoximetasone - Topicort | Taro Pharmaceuticals U.S.A., Inc. | Medical (PDF - 221 KB) | Clinical pharmacology (PDF - 302 KB) | None | PREA |
| Desvenlafaxine - Pristiq | Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. | Medica l (PDF - 103 KB)
Medical (PDF - 622 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Deutetrabenazine - Austedo | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 622 KB) | None | None | BPCA |
| Dexamethasone ophthalmic insert - DEXTENZA | Ocular Therapeutix, Inc. | Medical (PDF - 1 MB) | None | Statistical (PDF - 2 MB) | PREA |
| Dexlansoprazole - Dexilant | Takeda Pharmaceuticals USA Inc. | CDTL Review (PDF - 661 KB)
Medical (PDF- 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 50 KB) | PREA |
| Dexmedtomidine hydrochloride - Precedex | Hospira | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF -1 MB) | BPCA |
| Dexmedetomidine - Precedex | Hospira, Inc. | CDTL Review (PDF - 3 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 MB) | PREA |
| Dextroamphetamine - Xelstrym | Noven Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Diclofenac epolamine topical system 1.3% - Flector | IBSA Institut Biochimique SA | Medical (PDF - 1 MB) | None | None | PREA |
| Diclofenac potassium - Zipsor | Assertio Therapeutics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 453 KB) | None | PREA |
| Difamilast - Adquey | Acrotech Biopharma Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Difluprednate ophthalmic emulsion - Durezol | Alcon Pharmaceuticals Ltd. c/o Alcon Research Ltd | Medical (PDF -748 KB) | Clinical pharmacology (PDF - 40 KB) | Statistical (PDF - 479 KB) | BPCA |
| Dolutegravir and lamivudine - Dovato | ViiV Healthcare Company | Medical (PDF - 2 MB) | None | None | PREA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 11 MB) | Statistical (PDF - 4 MB) | PREA |
| Dolutegravir - Tivicay | ViiV Healthcare | Medical (PDF - 2 MB)
CDTL Review (PDF - 932 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Dolutegravir - Tivicay PD | ViiV Healthcare | Medical (PDF - 241 KB) | Clinical pharmacology (PDF - 89 KB) | None | PREA |
| Doravirine/lamivudine/tenofovir disoproxil fumarate - Delstrigo | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | CDTL Review (PDF - 962 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Dordaviprone - Modeyso | Chimerix, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Doxercalciferol - Hectorol | Genzyme Corporation | Medical (PDF - 4 MB) | None | None | PREA |
| Doxycycline hyclate delayed-release - Doryx | Mayne Pharma International, Pty, Ltd. c/o Warner Chilcott US, LLC | Medical (PDF - 241 KB) | Clinical pharmacology (PDF - 89 KB) | Statistical (PDF - 131 KB) | PREA |
| Doxycycline hyclate - LymePak | Chartwell Pharma NDA B2 Holdings, LLC | Medical (PDF - 1 MB) | None | None | PREA |
| Drospirenone and estetrol tablets - Nextstellis | Mayne Pharma LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Drospirenone - Slynd | Exeltis USA, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| Dulaglutide - Trulicity | Eli Lilly and Company | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 2 MB) | BOTH |
| Duloxetine - Cymbalta | Eli Lilly and Company, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 197 KB) | Statistical (PDF - 3 MB) | PREA |
| Duloxetine - Cymbalta | Eli Lily and Company, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Duloxetine delayed-release capsules - Drizalma Sprinkle | Sun Pharma Global FZE | Medical (PDF - 2 MB) | None | None | PREA |
| Duloxetine hydrochloride - Cymbalta | Eli Lilly and Company | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 959 KB) | Statistical (PDF - 665 KB) | BPCA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Dupilumab - Dupixent | Regeneron Pharmaceuticals, Inc. | Medical (PDF - 14 MB) | None | None | PREA |
| Econazole nitrate - Ecoza | AmDerma Pharmaceuticals, LLC | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 422 KB) | PREA |
| Eculizumab-aagh - Epysqli | Samsung Bioepis Co., Ltd. | Medical (PDF - 518 KB) | None | None | PREA |
| Edoxaban - Savaysa | Daiichi Sankyo, Inc. | CDTL (PDF - 4 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Efavirenz, lamivudine, tenofovir - Symfi Lo | Mylan Pharmaceuticals, Inc. | Medical (PDF - 129 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Efavirenz, lamivudine, tenofovir Disoproxil Fumarate - Symfi | Mylan Pharmaceuticals, Inc. | Medical (541 - KB) | None | None | PREA |
| Efavirenz, Lamivudine and Tenofovir disoproxil fumarate | Aurobindo Pharma Limited, India | DD Review (PDF - 65 KB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
| Efavirenz, lamivudine, tenofovir disoproxil fumarate | Macleods Pharmaceuticals Limited, India | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 788 KB) | None | PREA |
| Efavirenz - Sustiva | Bristol-Myers Squibb Company | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 9 MB) | None | BOTH |
| Efinaconazole - Jublia | Bausch Health Americas, Inc. | Medical (PDF - 538 KB) | None | None | PREA |
| Elbasvir and grazoprevir - Zepatier | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Eltrombopag - Alvaiz | Teva Pharmaceuticals Inc. | CDTL (PDF - 2 MB)
Medical (PDF - 583 MB) | Clinical pharmacology (PDF - 975 MB) | None | PREA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 58 KB) | None | None | BPCA |
| Eltrombopag - Promacta | Novartis Pharmaceuticals Corporation | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 97 KB) | BPCA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF - 13 MB) | Clinical pharmacology (PDF - 24 MB) | Statistical (PDF - 2 MB) | PREA |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF - 242 KB) | None | BOTH |
| Elvitegravir, Cobicistat, Emtricitabine, and Tenofovir alafenamide - Genvoya | Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | Clinical pharmacology (PDF - 9 MB) | None | BPCA |
| Elvitegravir, Cobicistat, Emtricitabine/Tenofovir Disoproxil Fumarate - Stribild | Gilead Sciences, Inc. | CTDL Review (PDF - 359 KB) | Clinical pharmacology (PDF - 462KB) | None | PREA |
| Empagliflozin - Jardiance | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical - CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | BPCA |
| Empagliflozin and Metformin - Synjardy | Boehringer Ingelheim Pharmaceuticals, Inc. | CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 3 MB) | BPCA |
| Empagliflozin and Metformin - Synjardy XR | Boehringer Ingelheim Pharmaceuticals, Inc. | CDTL (PDF - 7 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 3 MB) | BPCA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | CDTL (PDF - 7 MB) | None | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey | Gilead Sciences, Inc. | Medical (PDF 264 KB) | None | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Odefsey | Gilead Sciences, Inc. | Medical (PDF - 310 KB)
CTDL Review (PDF - 578 KB) | Clinical pharmacology (PDF - 5 MB)
Clinical pharmacology addendum (PDF - 297 KB) | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 1 MB)
Addendum (PDF - 572 KB) | Clinical pharmacology (PDF - 8 MB) | Statistical (PDF - 2 MB) | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 8 MB) | Statistical (PDF - 2 MB) | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 642 KB) | Clinical pharmacology (PDF - 145 KB) | None | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | CDTL Review (PDF - 2 MB) | None | None | PREA |
| Emtricitabine and tenofovir alafenamide - Descovy | Gilead Sciences, Inc. | Medical (PDF - 261 KB) | None | None | PREA |
| Emtricitabine, Rilpivirine, and Tenofovir isoproxil fumarate - Complera | Gilead Sciences, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF -145 KB) | None | PREA |
| Emtricitabine and Tenofovir disoproxil fumarate - Truvada | Gilead Sciences, Inc. | Medical (PDF - 501 KB) | Clinical pharmacology (PDF -189 KB) | None | PREA |
| Entecavir - Baraclude | Bristol-Myers Squibb Company | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 660 KB) | BOTH |
| Entrectinib - Rozlytrek | Genentech | Medical (PDF - 23 MB) | None | None | BPCA |
| Entrectinib - Rozlytrek | Genentech, Inc. | Medical (PDF - 14 MB) | None | None | BPCA |
| Erlotinib - Tarceva | OSI Pharmaceuticals, LLC | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Eribulin mesylate - Halaven | Eisai Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Epinephrine - Auvi-Q | Kaleo, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Epinephrine - Neffy | ARS Pharmaceuticals Operations, Inc. | Medical (PDF - 17 MB) | None | None | PREA |
| Epinephrine - Primatene Mist | Armstrong Pharmaceuticals, Inc. | CDTL Review (PDF - 2 MB)
Medical (PDF - 4 MB)
Medical 2 (PDF - 4 MB)
Division Director Review (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 660 KB)
Statistical 2 (PDF - 660 KB) | PREA |
| Epinephrine nasal spray - Neffy | ARS Pharmaceuticals Operations, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Escitalopram oxalate - Lexapro | Forest Laboratories, Inc. | Medical (PDF - 218 KB) | None | None | PREA |
| Escitalopram - Lexapro | AbbVie Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Eslicarbazepine acetate - Aptiom | Sunovion Pharmaceutical Inc. | CDTL Review (PDF - 593 KB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 KB) | None | PREA |
| Eszopiclone - Lunesta | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF -883KB) | None | BOTH |
| Etafilcon - Theravision with Ketotifen | Johnson & Johnson Vision Care, Inc. | DD Review (PDF - 2 MB)
Medical (PDF - 460 KB) | None | Statistical (PDF - 3 MB) | PREA |
| Etanercept - Enbrel | Immunex Corporation, a wholly-owned subsidiary of Amgen Inc. | Medical (PDF - 5 MB)
DD Review (PDF - 568 KB)
CDTL Review PDF - 504 KB) | Clinical pharmacology (PDF - 702 KB) | Statistical (PDF - 444 KB) | PREA |
| Etanercept - Enbrel | Amgen Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Etanercept-szzs - Erelzi | Sandoz Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 432 KB) | PREA |
| Etanercept-szzs - Erelzi | Sandoz Inc. | CDTL Review PDF - 504 KB) | None | None | PREA |
| Etanercept-szzs - Erelzi | Sandoz Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 7 MB) | None | BOTH |
| Etravirine - Intelence | Janssen Products, LP | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 896 KB) | None | BOTH |
| Everolimus tablets for oral suspension - Afinitor Disperz | Novartis Pharmaceuticals Corporation | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Evolocumab - Repatha | Amgen, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Exenatide - Bydureon | AstraZeneca Pharmaceuticals AB C/O AstraZeneca Pharmaceuticals LP | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB) | BOTH |
| Exenatide - Byetta | AstraZeneca AB | Medical (PDF - 802 KB) | Clinical pharmacology (PDF - 175 KB) | Statistical (PDF - 122 KB) | BOTH |
| Etonogestrel - Nexplanon | Organon USA LLC, a subsidiary of Organon & Co. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Fenfluramine HCl - Fintepla | Zogenix, Inc. | Medical (PDF - 588 KB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Ferric oxyhydroxide - Velphoro | Vifor Fresenius Medical Care Renal Pharma France | Medical (PDF - 1 MB) | None | None | BPCA |
| Ferric carboxymaltose - Injectafer | American Regent, Inc. | Medical (PDF - 613 KB) | Clinical pharmacology (PDF - 7 MB) | None | PREA |
| Ferric maltol - Accrufer | Shield TX (UK) Ltd. | Medical (PDF - 3 MB) |
| Fesoterodine fumarate - Toviaz | Pfizer, Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 300 KB) | BOTH |
| Fidaxomicin - Dificid | Cubist Pharmaceuticals LLC | Medical (PDF - 4 MB) | None | None | BPCA |
| Filgrastim-ayow - Releuko | Kashiv BioSciences, LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Filgrastim-sndz - Zarxio | Sandoz, Inc. | Medical (PDF - 4 MB)
DD Review (PDF - 86 KB)
TL Review (PDF - 422 KB) | Clinical pharmacology (PDF - 3 MB)
Addendum (PDF - 1 MB) | Statistical (PDF - 6 MB) | PREA |
| Filgrastim-aafi - Nivestym | Hospira, Inc. | CDTL Review (PDF - 746 KB)
Medical (PDF - 245 KB) | Clinical pharmacology (PDF - 661 KB) | Statistical (PDF - 377 KB) | PREA |
| Filgrastim-sndz - Zarxio | Sandoz Inc. | CDTL (PDF - 861 KB) | None | None | PREA |
| Finafloxacin otic suspension - Xtoro | Alcon Research, Ltd. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 3 MB) | BOTH |
| Fingolimod - Gilenya | Novartis Pharmaceuticals Corporation | CDTL Review (PDF - 2 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF -3 MB) | BOTH |
| Fingolimod - Tascenso ODT | Handa Neuroscience, LLC | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Fluticasone furoate inhalation powder - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 2 MB) | PREA |
| Fluticasone furoate - Arnuity Ellipta | GlaxoSmithKline | Medical (PDF - 956 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 507 KB) | PREA |
| Fluticasone furoate - Arnuity Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | Medical (PDF - 956 KB) | None | None | PREA |
| Fluticasone furoate - Flonase Sensimist Allergy Relief | Haleon US Holdings | Medical (PDF - 489 KB) | None | Statistical (PDF - 133 KB) | PREA |
| Fluticasone Furoate/Umeclidinium/Vilanterol - Trelegy Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England | Medical (PDF - 3 MB) | None | None | PREA |
| Fluticasone furoate/vilanterol - Breo Ellipta | GlaxoSmithKline | Medical (PDF - 16 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 4 MB) | PREA |
| Fluticasone furoate and vilanterol - Breo Ellipta | GlaxoSmithKline Intellectual Property Development Ltd. England C/o GlaxoSmithKline Research & Development | Medical (PDF - 6 MB) | None | None | BPCA |
| Fluticasone propionate Lotion - Cutivate | Fougera Pharmaceuticals Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Fluticasone propionate/salmeterol xinafoate - Advair HFA | GlaxoSmithKline | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 267KB) | Statistical (PDF - 52 KB) | PREA |
| Fluticasone propionate - ArmonAir RespiClick | Teva Pharmaceutical Industries Ltd. | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 KB) | PREA |
| Fluticasone propionate - ArmonAir RespiClick | Teva Pharmaceutical Industries Ltd. c/o: Teva Branded Pharmaceutical Products R&D Inc. | Medical (PDF - 6 MB) | None | None | BOTH |
| Fluticasone propionate/salmeterol - AirDuo | Teva Pharmaceutical Industries Ltd. | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 KB) | PREA |
| Folic acid - Quiofic NEW | CMP Development LLC | Medical (PDF - 29 KB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Fondaparinux sodium - Arixtra | Mylan Ireland Limited | Medical (PDF - 2 MB) | None | None | PREA |
| Formoterol fumarate and mometasone furoate - Dulera | Merck Sharp & Dohme Corp. | Medical (PDF - 10 MB) | None | None | BOTH |
| Fosaprepitant - Emend | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 662 KB) | BOTH |
| Fosaprepitant - Focinvez | Spes Pharmaceuticals Inc. | Unireview (PDF - 248 MB)
Unireview (PDF - 1 MB) | None | None | PREA |
| Fosphenytoin sodium - Cerebyx | Parke-Davis, a Division of Pfizer, Inc. | CDTL Review (PDF - 390 KB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 5 MB) | None | BPCA |
| Fremanezumab - Ajovy | Teva Pharmaceuticals USA, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Gadobutrol - Gadavist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 958 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 422 KB) | PREA |
| Gadobutrol - Gadavist | Bayer Healthcare Pharmaceuticals, Inc. | Medical (PDF - 7 MB) | None | Statistical (PDF - 782 KB) | PREA |
| Gadopiclenol - Elucirem | Guerbet LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF - 3 MB) | Clinical pharmacology (PDF -768KB) | Statistical (PDF - 1 MB) | PREA |
| Gadoterate meglumine - Dotarem | Guerbet LLC | Medical (PDF 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 398 KB) | PREA |
| Gadoteridol - ProHance | Bracco Diagnostics, Inc | Medical (PDF - 3 MB) | None | None | PREA |
| Gadoxetate disodium - Eovist | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Gatifloxacin ophthalmic solution - Zymar | Allergan, Inc. | Medical (PDF - 78 KB) | None | None | Both |
| Gatifloxacin - Zymar | Allergan, Inc. | DDTL (PDF - 428 KB) | None | None | Both |
| Gepirone - Exxua | Fabre-Kramer Pharmaceuticals, Inc. | Medical (PDF - 10 MB) | None | None | Both |
| Gepotidacin - Blujepa | GlaxoSmithKline, LLC | Medical (PDF - 9 MB) | None | None | PREA |
| Gepotidacin - Blujepa | GlaxoSmithKline, LLC (GSK) | Medical (PDF - 4 MB) | None | None | PREA |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. | CTDL (PDF - 2 MB)
CTDL Addendum (PDF - 187 KB) | Clinical pharmacology (PDF - 409 KB) | Statistical (PDF - 439 KB) | PREA |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie Inc. | Medical (PDF - 78 KB) | None | None | BOTH |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | None | BOTH |
| Glecaprevir and Pibrentasvir - Mavyret | AbbVie, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Glucagon - Gvoke | Xeris Pharmaceuticals, Inc. | Medical (PDF - 3 MB)
CTDL Review (PDF - 3 MB | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glucagon - Baqsimi | Amphastar Pharmaceuticals, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Glucagon - Baqsimi | Eli Lilly and Company | Medical (PDF - 3 MB)
CTDL Review (PDF - 3 MB | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Glycopyrronium - Qbrexza | Dermira, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Golimumab - Simponi | Janssen Biotech, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 307 KB) | Statistical (PDF - 1 MB) | PREA |
| Golimumab - Simponi Aria | Janssen Biotech, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Guanfacine - Intuniv | Shire | Medical (PDF - 2 MB)
CTDL Review (PDF - 134 KB) | Clinical pharmacology (PDF - 330 KB) | Statistical (PDF - 544 KB) | Both |
| Guanfacine - Intuniv | Shire | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 667 KB) | Statistical (PDF - 3 MB) | PREA |
| Guselkumab - Tremfya | Janssen Biotech, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Guselkumab - Tremfya | Janssen Biotech, Inc. | Medical (PDF - 15 MB) | None | None | PREA |
| Halobetasol - Propionate Ultravate | Sun Pharmaceutical Industries, Inc. | Medical (PDF - 150 KB) | Clinical pharmacology (PDF - 303 KB) | None | PREA |
| Halobetasol Propionate - Lexette | Mayne Pharma LLC | Medical (PDF - 249 KB) | Clinical pharmacology (PDF - 752 KB) | None | BOTH |
| Hydrochlorothiazide- INZIRQO | Novitium Pharma LLC | CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Ibrexafungerp - Brexafemme | SCYNEXIS, Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Ibrexafungerp - Brexafemme | SCYNEXIS, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Ibrutinib - Imbruvica | Pharmacyclics LLC | Medical (PDF - 20 MB) | None | None | BPCA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | CTDL Review (PDF - 134 KB) | Clinical pharmacology (PDF - 752 KB) | None | PREA |
| Ibuprofen - Caldolor | Cumberland Pharmaceuticals, Inc. | DD Summary Review (PDF - 669 KB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 378 KB) | PREA |
| Imatinib - IMKELDI | Shorla Pharma Ltd | Medical (PDF - 785 KB) | None | None | PREA |
| Imipenem, Cilastatin, and Relebactam - Recarbrio | Merck Sharp & Dohme LLC | Medical (PDF - 7 MB) | None | None | PREA |
| Iomeprol - Iomervu | Bracco Diagnostics Inc | Medical (PDF - 2 MB) | None | None | PREA |
| IncobotulinumtoxinA - Xeomin | Merz Pharmaceuticals GmbH | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
| incobotulinumtoxinA - Xeomin | Merz Pharmaceuticals GmbH | Medical (PDF - 1 MB) | None | Statistical (PDF - 872 KB) | PREA |
| Indocyanine green for Injection - Spy Agent Green | Novadaq Technologies ULC | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-axxq - Avsola | Amgen, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Infliximab-dyyb - Inflectra | Celltrion, Inc. | Medical (PDF - 5 MB)
Addendum (PDF - 1 MB) | None | Statistical (PDF -2 MB) | PREA |
| Infliximab-abda - Renflexis | Samsung Bioepsis Co., Ltd | CDTL Review (PDF - 1 MB)
Medical (PDF - 4 MB)
Medical 2 (PDF - 267 KB)
Medical 3 (PDF - 93 KB) | Clinical pharmacology (PDF - 8 MB) | Statistical (PDF - 959 KB)
Statistical 2 (PDF - 602 KB) | PREA |
| Insulin aspart injection - Fiasp | Novo Nordisk Inc. | CDTL Review (PDF - 1 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 905 KB) | PREA |
| Insulin aspart-szjj - Merilog & Merilog - SoloStar | Sanofi-Aventis U.S. LLC | CDTL Review (PDF - 250 KB)
Medical (PDF - 4 MB) | None | None | PREA |
| Insulin Degludec - Tresiba | Novo Nordisk Inc. | CDTL Review (PDF - 7 MB)
Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 905 KB) | PREA |
| Insulin Degludec / Insulin Aspart) - Ryzodeg | Novo Nordisk Inc. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 905 KB) | PREA |
| Insulin glargine-yfgn - Semglee | Mylan Pharmaceuticals Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Insulin glargine-aglr - Rezvoglar | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Insulin lispro-aabc - Lyumjev | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 10 MB)
Clinical pharmacology
addendum (PDF - 10 KB) | Statistical (PDF - 253 KB) | PREA |
| Iodixanol - Visipaque | GE HealthCare Inc. | CDTL Review (PDF - 2 MB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 988 KB) | Statistical (PDF - 2 MB) | PREA |
| Iohexol - Oraltag | Interpharma Praha, a.s. | Medical (PDF - 91 KB) | Clinical pharmacology (PDF - 294 KB) | Statistical (PDF - 98 KB) | PREA |
| Iopamidol - Isovue | Bracco Diagnostics Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Ipilimumab - Yervoy | Bristol-Myers Squibb Company | Medica l (PDF 6 MB) | Clinical pharmacology (PDF - 2 MB) | None | BPCA |
| Ipilimumab - Yervoy | Bristol-Myers Squibb Company | Medical (PDF 20 MB) | None | None | BPCA |
| Iron Sucrose Injection, USP - Venofer | Luitpold Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 114 KB) | Statistical (PDF - 576 KB) | PREA |
| Isavuconazonium sulfate - Cresemba | Astellas Pharma US Inc. | Medical (PDF - 5 MB) | None | None | BPCA |
| Ivabradine - Corlanor | Amgen Inc. | CDTL (PDF - 3 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 51 KB) | BPCA |
| Ivacaftor - Kalydeco | Vertex Pharmaceuticals Incorporated | Medical (PDF - 4 MB) | None | None | BPCA |
| Ivacaftor - Kalydeco | Vertex Pharmaceuticals Inc. | Medical (PDF - 4 MB) | None | None | BPCA |
| Ivacaftor and lumacaftor - Orkambi | Vertex Pharmaceuticals Incorporated | Medical (PDF - 1 MB) | None | None | PREA |
| Ixekizumab - Taltz | Eli Lilly and Company | Medical (PDF - 2 MB) | None | None | PREA |
| Kit for the preparation of technetium Tc 99m-labeled carbon inhalation aerosol - Technegas | Cyclomedica Australia Pty Ltd. | Medical (PDF - 1 MB) | None | None | PREA |
| Kit for the Preparation of Technetium Tc 99m Pentetate Injection - Draximage | Jubilant DraxImage, Inc | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
| Lacosamide - Motpoly XR | Aucta Pharmaceuticals, Inc. | Medical (PDF - 276 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Lacosamide - Vimpat | UCB, Inc. | CDTL Review (PDF - 371 KB)
Medical (PDF - 915 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 541 KB)
Medical (PDF - 631 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 700 KB) | Clinical pharmacology (PDF - 800 KB) | None | PREA |
| Lacosamide - Vimpat | UCB, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 9 MB) | PREA |
| Lactic acid citric acid and K bitartrate - Phexxi | Evofem, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 KB) | Statistical (PDF - 3 KB) | PREA |
| Lamivudine - Epivir | ViiV Healthcare Company | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 3 MB) | | PREA |
| Lamivudine and Raltegravir - Dutrebis | Merck Sharp & Dohme Corp. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 6 MB) | None | PREA |
| Lamivudine and tenofovir - Cimduo | Mylan Pharmaceuticals India | Medical (PDF - 73 KMB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Lamivudine and tenofovir disoproxil fumarate - Temixys | Celltrion, Inc. | Medical (PDF - 20 KB)
DDTL (PDF - 166 KB) | Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology addendum (PDF - 166 KB) | None | PREA |
| Lamotrigine - Lamictal | GlaxoSmithKline LLC | Medical (PDF - 18 MB) | Clinical pharmacology (PDF - 793 KB) | Statistical (PDF - 2 MB) | PREA |
| Lamotrigine - Subvenite | OWP Pharmaceuticals, Inc. | CDTL 1 (PDF - 123 MB)
CDTL 2 (PDF - 1 MB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 417 KB) | None | PREA |
| Lanadelumab-flyo - Takhzyro | Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 7 MB) | None | None | BPCA |
| Lebrikizumab-lbkz - Ebglyss | Eli Lilly and Company | Medical (PDF - 142 KB)
Uniview (PDF - 10 MB) | None | None | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical and CDTL (PDF - 2 MB) | Clinical pharmacology (PDF - 539 KB) | Statistical (PDF - 205 KB) | PREA |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | Medical (PDF - 426 KB) | None | None | BOTH |
| Ledipasvir-sofosbuvir - Harvoni | Gilead Sciences, Inc. | CDTL (PDF - 31 KB) | None | None | PREA |
| Lenacapavir - Yeztugo | Gilead Sciences, Inc. | Medical (PDF -12 MB) | None | None | PREA |
| Lenvatinib - Lenvima | Eisai Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Leuprolide acetate - Fensolvi | Tolmar, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 4 MB | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol hydrochloride - Xopenex | Oak Pharmaceuticals | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Levalbuterol tartrate - Xopenex HFA | Sunovion Pharmaceuticals Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF 1 MB) | PREA |
| Levamlodipine - Conjupri | CSPC Ouyi Pharmaceutical Co., Ltd. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 569 KB) | None | PREA |
| Levetiracetam - Keppra Extended Release Tablets | UCB, Inc. | DD Summary Review (PDF - 202 KB)
CDTL Review (PDF - 371 KB)
Medical (PDF - 327 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Levetiracetam - Spritam | Aprecia Pharmaceuticals | Medical (PDF - 4 MB) | None | None | PREA |
| Levomilnacipran - Fetzima | AbbVie Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Levonorgestrel - Liletta | Medicines360 | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Levonorgestrel/ethinyl estradiol tablets - Tyblume | Exeltis | CDTL (PDF - 9 MB)
Medical (PDF - 9 MB)
Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 2 MB) | PREA |
| Levonorgestrel/ethinyl estradiol and ethinyl estradiol - Quartette | Teva Branded Pharmaceutical Products R&D, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 4 MB)
Clinical pharmacology addendum (PDF - 89 KB) | Statistical (PDF - 1 MB) | PREA |
| Levonorgestrel-releasing intrauterine system - Skyla | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 424 KB) | PREA |
| Levonorgestrel releasing intrauterine system - Liletta | Medicines360 | CDTL Review (PDF - 179 KB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 168 KB) | PREA |
| Levonorgestrel - Mirena | Bayer HealthCare Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Levothyroxine sodium oral solution - Tirosint-SOL | Cromsource, Inc. | CDTL Review (PDF - 461 KB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Linaclotide - Linzess | AbbVie Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Linaclotide - Linzess NEW | AbbVie Inc. | Medical (PDF - 2 MB) | None | None | BOTH |
| Linagliptin - Tradjenta | Boehringer Ingelheim Pharmaceuticals, Inc | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | BOTH |
| Lipid injectable emulsion - SMOFlipid | Fresenius Kabi USA, LLC | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Liraglutide - Saxenda | Novo Nordisk, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 2 MB) | PREA |
| Liraglutide - Victoza | Novo Nordisk Inc. | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 864 KB) | Statistical (PDF - 450 KB) | BOTH |
| Lisdexamphetamine dimesylate - Arynta | Azurity Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Lisdexamfetamine dimesylate - Vyvanse | Shire Development, LLC | Medical (PDF - 218 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Lisdexamfetamine dimesylate - Vyvanse | Shire | Medical (PDF - 2 MB) | None | Statistical (PDF - 1 MB) | PREA |
| Lisdexamfetamine dimesylate - Vyvanse | Takeda Pharmaceuticals U.S.A., Inc. | Medical (PDF - 804 KB) | None | None | BOTH |
| Lisenatide - Adlyxin | Sanofi-aventis U.S. LLC | Medical (PDF - 182 KB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Losartan potassium - Arbli | Scienture LLC | Medical (PDF - 176 KB)
CDTL1 (PDF - 707 KB)
CDTL2 (PDF - 22 KB) | Clinical pharmacology (PDF - 2 MB) | | PREA |
| Lumacaftor and ivacaftor - Orkambi | Vertex Pharmaceuticals Incorporated | Medical (PDF - 6 MB) | None | None | BPCA |
| Loteprednol - Lotemax | Bausch & Lonb Inc. | Medical (PDF - 318 KB)
Medical (PDF - 218 KB) | None | Statistical (PDF - 3 MB) | PREA |
| Luliconazole - LuzuTM | Medicis Pharmaceutical Corporation, a division of Valeant Pharmaceuticals NA LLC | CDTL (PDF - 358 KB)
CDTL (PDF - 372 KB)
Medical (PDF - 306 KB)
Medical (PDF - 616 KB) | Clinical pharmacology (PDF - 1 MB)
Clinical pharmacology (PDF - 423 KB) | Statistical (PDF - 207 KB) | PREA |
| Lopinavir / Ritonavir - Kaletra | AbbVie Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Lubiprostone - Amitizia | Sucampo Pharmaceuticals Inc. | Medical (PDF - 11 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Lutetium Lu177 dotatate - Lutathera | Advanced Accelerator Applications USA, Inc. | Medical (PDF - 3 MB) | None | None | BPCA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 6 MB)
Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 369 KB)
Statistical (PDF - 255 KB) | BOTH |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. | CDTL (PDF - 6 MB)
Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 368 KB) | PREA |
| Lurasidone hydrochloride - Latuda | Sunovion Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Macitentan - Opsumit | Actelion Pharmaceuticals US, Inc. | Medical (PDF - 14 MB) | None | None | BPCA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Maraviroc - Selzentry | Viiv Healthcare | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | BPCA |
| Memantine hydrochloride - Namenda XR | Forest Research Institute, Inc. (subsidiary of Forest Laboratories Inc.) | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 956 KB) | Statistical (PDF - 1 MB) | BPCA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 6 MB)
Clinical pharmacology addendum (PDF - 425 KB) | Statistical (PDF - 1 MB) | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Mepolizumab - Nucala | GlaxoSmithKline LLC | Medical (PDF - 8 MB) | None | None | PREA |
| Mirabegron - Myrbetriq | Astellas Pharma Global Development, Inc. | Medical (PDF - 13 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 168 KB) | BOTH |
| Mesalamine - Asacol HD | Warner Chilcott | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 3 MB)
Clinical pharmacology (PDF - 518 KB) | Statistical (PDF - 499 KB) | PREA |
| Mesalamine - Canasa | Forest Laboratories | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 251 KB) | Statistical (PDF - 344 KB) | PREA |
| Mesalamine - Delzicol | Warner Chilcott LLC | Medical (PDF - 707 KB)
Medical Addendum (PDF - 495 KB) | Clinical pharmacology (PDF - 116 KB) | None | PREA |
| Mesalamine - Delzicol | Warner Chilcott (US), LLC | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 729 KB) | Statistical (PDF - 1 KB) | PREA |
| Mesalamine - Lialda | Shire Development, LLC | Medical (PDF - 6 MB) | None | None | PREA |
| Metformin hydrochloride for extended-release oral suspension - Riomet ER | Pharmaceutical Industries Limited | CTDL Review (PDF - 917 KB) | Clinical pharmacology (PDF - 818 KB) | None | PREA |
| 10% Methyl salicylate, 3% L-menthol - Salonpas Pain Relief | Hisamitsu Pharmaceutical Co., Inc. | Medical (PDF - 998 KB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | PREA |
| Methylphenidate hydrochloride extended-release - Aptensio XR | Rhodes Pharmaceuticals L.P. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 MB)
Statistical (PDF - 629 KB) | PREA |
| Methylphenidate hydrochloride - Aptensio XR | Rhodes Pharmaceuticals L.P. | CTDL Review (PDF - 592 KB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB)
Statistical (PDF - 139 KB) | BOTH |
| Methylphenidate hydrochloride - Quillivant XR | NextWave Pharmaceuticals, Inc. | Medical (PDF - 26 KB) | Clinical pharmacology (PDF - 588 KB) | Statistical (PDF - 380 KB) | PREA |
| Methylphenidate hydrochloride extended release chewable tablets - QuilliChew ER | Pfizer Inc. | CTDL Review (PDF -1 MB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 498 KB) | PREA |
| Methylphenidate HCL extended-release capsules - Adhansia XR | Purdue Pharma | Medical (PDF - 2 MB)
Medica l (PDF - 5 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB)
Statistical (PDF - 2 MB) | PREA |
| Methylphenidate hydrochloride - Jornay PM | Ironshore Pharmaceuticals & Development, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 921 KB) | PREA |
| Methylphenidate extended-release orally disintegrating tablets - Cotempla XR-ODT | Neos Therapeutics, Inc. | Medical (PDF - 6 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 921 KB)
Statistical (PDF - 96 KB) | PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera | Vifor International AG | Medical (PDF - 2 MB) | None | Statistical (PDF - 239 KB) | PREA |
| Methoxy polyethylene glycol-epoetin beta - Mircera | Vifor (International) AG c/o ProPharma Group | Medical (PDF - 7 MB) | Clinical Pharmacology (PDF - 5 MB) | Statistical (PDF - 7 MB) | PREA |
| Metoprolol Succinate - KAPSPARGO SPRINKLE | Sun Sun Pharmaceutical Industries LimitedPharmaceutical Industries Limited | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 978 KB) | None | PREA |
| Metronidazole - Likmez | Saptalis Pharmaceuticals, LLC | Medical (PDF - 6 MB) | None | None | PREA |
| Metronidazole vaginal gel 1.3% - Nuvessa | Chemo Research SL | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 70 KB) | Statistical (PDF - 127 KB) | PREA |
| Micafungin for Injection - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 1 MB) | None | None | BOTH |
| Micafungin in Sodium Chloride Injection | Baxter HealthCare Corporation | Medical (PDF - 1 MB) | None | None | PREA |
| Micafungin sodium - Mycamine | Astellas Pharma US, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 987 KB) | BPCA |
| Minocycline - Amzeeq | Foamix Pharmaceuticals Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Mirabegron extended-release tablets and mirabegron extended-release for oral suspension - Myrbetriq and Myrbetriq Granules | Astellas Pharma Global Development, Inc. | Medical (PDF - 13 MB) | None | None | BOTH |
| Mixed salts of a single-entity amphetamine product - Mydayis | Shire Development, LLC. | Medical (PDF - 7 MB) | Clinical pharmacology (PDF - 2 KB) | Statistical (PDF - 987 KB) | PREA |
| Mixed salts of a single entity amphetamine product - Mydayis | Shire Development, LLC. | Medical (PDF - 7 MB) | None | None | BPCA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohme Corp. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 603 KB) | PREA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohm Corp | Medical (PDF- 1 MB) | None | None | PREA |
| Mometasone furoate - Asmanex HFA | Merck Sharp & Dohm Corp | Medical (PDF - 1 MB) | None | None | PREA |
| Mometasone furoate and formoterol fumarate - Dulera | Schering-Plough | Medical (PDF- 1 MB) | None | None | PREA |
| Morphine sulfate - Morphine sulfate | Hospira, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Morphine sulfate - Morphine sulfate | Hikma Pharmaceuticals USA Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Moxifloxacin - Avelox | Bayer Pharmaceuticals | Medical (PDF- 905 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 760 KB) | PREA |
| Moxifloxacin ophthalmic solution - Vigamox | Alcon Pharmaceuticals, Ltd. | Medical (PDF - 434 KB)
DD Summary Review (PDF- 118 KB) | None | None | BPCA |
| Mycophenolate mofetil - CellCept | Roche Palo Alto LLC | Medical (PDF - 6 MB) | None | None | PREA |
| Mycophenolate mofetil oral suspension - Myhibbin | Liqmeds Worldwide Limited | Unireview (PDF - 10 MB)
Medical (PDF - 353 KB) | None | None | PREA |
| Naftifine hydrochloride - Naftin NEW | Merz Pharmaceuticals, LLC | Medical (PDF - 488 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 188 KB) | PREA |
| Naftifine hydrochloride - Naftin Cream, 2% | Merz Pharmaceuticals, LLC | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 822 KB) | PREA |
| Nalmefene - Opvee | Opiant Pharmaceuticals, Inc. | CTDL Review (PDF - 4 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 9 MB)
Clinical pharmacology addendum (PDF - 9 KB) | Statistical (PDF - 2 MB) | PREA |
| Nalmefene injection - Zurnai | Purdue Pharma, L.P. | CDTL-DD (PDF - 2 MB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 5 MB) | None | PREA |
| Naloxone hydrochloride - Kloxxado | Hikma Pharmaceuticals USA, Inc. | CTDL Review (PDF - 613 KB)
CTDL and DD Review (PDF - 1 MB)
Medical (PDF - 4 MB) | None | None | PREA |
| Naloxone hydrochloride - Kloxxado | Hikma Pharmaceuticals USA, Inc. | CTDL Review (PDF - 359 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Naloxone hydrochloride - Narcan Nasal Spray | Adapt Pharma Operations Limited | DD Summary Review (PDF -1 MB)
CTDL Review (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Naloxone Hydrochloride Injection - Naloxone Hydrochloride Injection | Kaleo, Inc. | CDTL Review (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Naloxone Hydrochloride - Rextovy | Amphastar Pharmaceuticals, Inc | Medical (PDF - 3 MB)
CDDD Review (PDF - 637 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Naloxone Hydrochloride - Rezenopy | Summit Biosciences | Medical (PDF - 2 MB)
CDTL Review (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Naloxone hydrochloride - RiVive | Harm Reduction Therapeutics, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Naloxone hydrochloride - Zimhi | Adamis Pharmaceuticals Corporation | CDTL Review (PDF - 2 MB) | Clinical pharmacology (PDF - 368 KB) | None | PREA |
| Naproxen sodium/dextromethorphan HBr/guaifenesin - Mucinex 12 HR Cold & Fever Multi-Symptom NEW | RB Health (US) LLC | Medical (PDF - 3 MB)
Unireview (PDF - 1 MB) | None | None | PREA |
| Naproxen sodium 220 mg and Diphenhydramine hydrochloride - Aleve PM | Bayer HealthCare, LLC – Consumer Care | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 1 MB) | PREA |
| Naproxen and esomeprazole magnesium - Vimovo | Horizon Pharma Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Neostigmine methylsulfate - Bloxiverz | Eclat Pharmaceuticals, LLC | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Neostigmine methylsulfate and glycopyrrolate - Prevduo | Slayback Pharma LLC | CDTL Review (PDF - 794 KB) | Clinical pharmacology (PDF - 284 KB) | None | PREA |
| Nevirapine - Viramune XR | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 446 KB) | Statistical (PDF - 723 KB) | PREA |
| Nilotinib - Tasigna | Novartis Pharmaceuticals Corporation | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 124 KB) | BPCA |
| Nintedanib - Ofev | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 10 MB) | None | None | BPCA |
| Nintedanib - Ofev | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 249 KB) | None | None | BCPA |
| Nirmatrelvir - Ritonavir - Paxlovid | Pfizer, Inc | Medical (PDF - 27 MB) | None | None | PREA |
| Nirsevimab-alip - Beyfortus | AstraZeneca AB | Medical (PDF - 20 MB) | None | None | PREA |
| Nirsevimab-alip - Beyfortus | AstraZeneca AB | Medical (PDF - 2 MB) | None | None | PREA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | Clinical pharmacology (PDF - 4 MB) | None | PREA |
| Nitisinone - NITYR | Cycle Pharmaceuticals Ltd. | Medical (PDF - 358 KB) | None | None | PREA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | DD (PDF - 188 KB)
Medical (PDF - 222 KB) | Clinical pharmacology (PDF - 202 KB)
Clinical pharmacology (PDF - 250 KB) | None | PREA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | Medical (PDF - 8 MB) | None | None | BPCA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | Medical (PDF - 11 MB) | None | None | BPCA |
| Nivolumab - Opdivo | Bristol-Myers Squibb Company | Medical (PDF - 17 MB) | None | None | PREA |
| Nivolumab and hyaluronidase-nvhy - Opdivo Qvantig | Bristol-Myers Squibb Company | Medical (PDF - 1 MB) | None | None | PREA |
| Nivolumab and relatlimab-rmbw - Opdualag | Bristol-Myers Squibb Company | Medical (PDF - 29 MB) | None | None | PREA |
| Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules - Taytulla | Warner Chilcott Company, LLC | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 469 KB) | PREA |
| Norethindrone acetate and ethinyl estradiol - Femlyv | Millicent Puerto Rico LLC | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Obiltoxaximab - Anthim | Elusys Theraputics, Inc. | Medical (PDF -18 MB)
Addendum (PDF - 249 KB) | Clinical pharmacology (PDF - 12 MB)
Addendum (PDF - 126 KB) | Statistical (PDF - 9 MB) | PREA |
| Ocriplasmin- Jetrea | ThromboGenics, Inc. | Medical (PDF - 817 KB) | Clinical pharmacology (PDF - 117 KB) | Statistical (PDF - 760 KB) | PREA |
| Olanzapine and fluoxetine hydrochloride - Symbyax | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB)
Addendum (PDF - 132 KB) | Statistical (PDF - 953 KB) | PREA |
| Olopatadine - Pazeo | Alcon Research LTD | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 340 KB) | Statistical (PDF - 4 KB) | BOTH |
| Olopatadine hydrochloride and mometasone furoate - Ryaltris | Glenmark Specialty SA | Medical (PDF - 6 MB)
CDTL (PDF - 6 MB) | None | None | PREA |
| Omalizumab - Xolair | Genentech | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | PREA |
| Omalizumab - Xolair | Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF- 4 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Omalizumab - Xolair | Genentech, Inc. and Novartis Pharmaceuticals Corp. | Medical (PDF - 5 MB) | None | None | PREA |
| Omalizumab - Xolair | Genentech, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Omeprazole magnesium - Prilosec | AstraZeneca Pharmaceuticals LP | Medical (PDF - 908 KB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| OnabotulinumtoxinA - Botox | Allergan, Inc. | CDTL (PDF - 403 KB)
Medical (PDF - 1 MB) | None | Statistical (PDF - 173 KB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc | Medical (PDF - 3 MB)
Medical (PDF - 1 MB) | None | Statistical (PDF - 1 MB) | PREA |
| OnabotulinumtoxinA - Botox | Allergen, Inc | Medical (PDF - 1 MB) | None | None | PREA |
| OnabotulinumtoxinA - Botox | Allergan, Inc. | Medical (PDF - 1 MB) | None | Statistical (PDF - 2 MB) | PREA |
| OnabotulinumtoxinA - Botox | Allergan, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Oxaprozin - Coxanto | Solubiomix, Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Oxcarbazepine - Oxtellar XR | Supernus Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 7 MB) | Statistical (PDF - 482 KB) | PREA |
| Oxycodone hydrochloride - Oxycodone hydrochloride | Genus Lifesciences, Inc. | Medical (PDF - 2 MB)
DD Memo (PDF - 1 MB) | Clinical pharmacology (PDF - 688 KB) | None | PREA |
| Oxycodone hydrochloride - Oxycontin | Purdue Pharma L.P. | Medical (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 678 KB) | BPCA |
| Oxymorphone - Opana | | Med i cal (PDF - 17 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Ozenoxacin - Xepi | Ferrer Internacional S.A. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 524 KB) | PREA |
| Paclitaxel - Abraxane | Abraxis BioScience, L.L.C., a wholly-owned subsidiary of Celgene Corporation | Medical (PDF - 235 KB) | None | None | BPCA |
| Palbocilib - Ibrance | Pfizer Inc. | CDTL - DD (PDF - 161 KB) | Clinical pharmacology (PDF - 232 KB) | None | BPCA |
| Palifermin - Kepivance | Quintiles, Inc. | Medical (PDF - 280 KB) | Clinical pharmacology (PDF - 726 KB) | None | PREA |
| Palonosetron hydrochloride - Aloxi | Helsinn Healthcare SA | Medical (PDF - 15 MB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 771 KB) | BOTH |
| Pancrelipase - Creon | AbbVie Inc. | Medical (PDF - 566 KB) | None | None | PREA |
| Pancrelipase - Pancreaze | Janssen Pharmaceuticals, Inc. | Medical (PDF - 142 KB) | None | None | PREA |
| Pancrelipase - Pertzye | Digestive Care, Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Pancrelipase - Zenpep | Aptalis Pharma Limited. | Medical (PDF - 587 KB) | None | None | PREA |
| Pantoprazole sodium - Protonix IV | Wyeth Pharmaceuticals LLC | Medical (PDF - 4 MB) | None | None | PREA |
| Paricalcitol - Zemplar | AbbVie Inc. | Medical (PDF - 3 MB)
CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 427 KB) | PREA |
| Patiromer - Veltassa | Vifor Pharma, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Pegfilgrastim-cbqv - UDENYCA | Coherus BioSciences, Inc | Medical (PDF - 184 KB)
Medical (PDF - 228 KB)
CDTL (PDF - 584 KB) | Clinical pharmacology (PDF - 968 KB) | Statistical (PDF - 199 KB) | PREA |
| Pegfilgrastim-fpgk - Stimufend | Fresenius Kabi USA, LLC | CDTL (PDF - 198 KB) | None | None | PREA |
| Pegfilgrastim-bmez - Ziextenzo | Sandoz Inc. | CDTL (PDF - 348 KB) | None | None | PREA |
| Pegfilgrastim-pbbk - Fylnetra | Kashiv BioSciences, LLC | CDTL (PDF - 30 KB) | None | None | PREA |
| Pegfilgrastim-unne - Armlupeg | Lupin Limited (Biotech Division) | CDTL (PDF - 58 KB)
Medical (PDF - 2 MB) | None | None | PREA |
| Peginterferon alfa-2a - Pegays | Hoffmann-La Roche, Incorporated | Medical (PDF - 799 KB) | Clinical pharmacology (PDF - 667 KB) | Statistical (PDF - 667 KB) | PREA |
| Pembrolizumab and berahyaluronidase alfa-pmph - Keytruda Qlex | Merck Sharp & Dohme LLC | Medical (PDF - 15 MB) | None | None | PREA |
| Peramivir - Rapivab | BioCryst Pharmaceuticals, Inc. | Medical (PDF - 767 KB | Clinical pharmacology (PDF - 468 KB) | Statistical (PDF - 767 KB) | PREA |
| Peramivir - Rapivab | BioCryst Pharmaceuticals, Inc. | Medical (PDF - 1 MB | Clinical pharmacology (PDF - 81 KB) | None | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF -1 MB) | PREA |
| Perampanel - Fycompa | Eisai, Inc. | Medical (PDF - 3 MB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 4 MB) | Statistical (PDF - 1 MB) | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF - 3 MB)
Medical MTL (PDF - 678 KB) | Clinical pharmacology (PDF -1 MB) | None | PREA |
| Perampanel - Fycompa | Eisai Inc. | Medical (PDF - 79 KB) | Clinical pharmacology (PDF - 86 KB) | None | PREA |
| Perampanel - Fycompa | Eisai Inc. | CDTL (PDF - 452 KB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Perflutren lipid microsphere - DEFINITY and DEFINITY RT | Lantheus Medical Imaging, Inc. | Medical (PDF - 719 KB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 858 KB) | PREA |
| Pentermine and topiramate - Qsymia | VIVUS LLC | Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 587 KB) | Statistical (PDF - 858 KB) | PREA |
| Phentolamine mesylate - OraVerse | Septodont Holding Sas | Medical (PDF - 3 MB) | None | Statistical (PDF - 1 MB) | PREA |
| Phenylephrine hydrochloride ophthalmic solution | Paragon BioTeck, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 95 KB) | Statistical (PDF -1 MB) | PREA |
| Phentolamine ophthalmic solution - Ryzumvi | Ocuphire Pharma, Inc. | CDTL (PDF - 1 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Phenylephrine and ketorolac - Omidria | Omeros Corporation | CDTL (PDF - 1 MB)
Medical (PDF - 4 MB) | None | Statistical (PDF - 816 KB) | BPCA |
| Piperacillin and tazobactam - Zosyn | Wyeth Pharmaceuticals LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Pitavastatin - Livalo | Kowa Pharmaceuticals America, Inc. | CDTL Review (PDF - 526 KB)
Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 240 KB) | BPCA |
| Pomalidomide - POMALYST | Celgene Corporation | Medical (PDF - 15 KB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 252KB) | PREA |
| Posaconazole - Noxafil | Merck | Medical (PDF - 602 KB) | Clinical pharmacology (PDF - 645 KB) | None | PREA |
| Posaconazole - Noxafil | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Potassium phosphate | Fresenius Kabi USA, LLC | Medical (PDF - 602 KB) | None | None | PREA |
| Potassium Phosphates - Potassium Phosphate | CMP Development LLC | Medical (PDF - 3 MB) | None | None | PREA |
| Prasugrel - Effient | Eli Lilly and Company | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 911 KB) | Statistical (PDF - 290 KB) | BPCA |
| Pregabalin - Lyrica | Pfizer | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 6 KB) | Statistical (PDF - 825 KB) | PREA |
| Pregabalin - Lyrica | PF PRISM CV | Medical and Statistical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Medical and Statistical (PDF - 1 MB) | PREA |
| Pregabalin - Lyrica | Pfizer | CTDL Review (PDF - 1 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 2 MB) | BOTH |
| Prucalopride - Motegrity | Takeda Pharmaceuticals U.S.A Inc. | Medical (PDF - 1 MB) | None | None | PREA |
| Quetiapine fumarate - Seroquel and Seroquel XR | AstraZeneca Pharmaceuticals LP | CTDL Review (PDF - 1 MB)
Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 739 KB) | Statistical (PDF - 785 KB) | PREA |
| Rabeprazole sodium - AcipHex Sprinkle | Eisa Inc. | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF 185 KB) | BOTH |
| Ramucirumab - Cyramza | Eli Lilly and Company | Medical (PDF - 198 KB) | Clinical pharmacology (PDF - 168 KB) | None | BPCA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | None | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | CDTL Review (PDF - 5 MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF 874 KB) | PREA |
| Raltegravir - Isentress | Merck Sharp Dohme Corp | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BOTH |
| Ravulizumab-cwvz - Ultomiris | Alexion Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. | Medical (PDF - 1 MB)
Medical (PDF - 776 KB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 225 KB)
Statistical (PDF - 782 KB) | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. | CDTL (PDF - 3 MB) | None | None | PREA |
| Remdesivir - Veklury | Gilead Sciences, Inc. | CDTL (PDF - 4 MB) | None | None | BOTH |
| Reslizumab - Cinqair | Teva Respiratory, LLC | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 9 MB) | Statistical (PDF - 2 MB) | PREA |
| Revumenib - Revuforj | Syndax Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Rifapentin - Priftin | Sanofi US Services Inc. | Medical (PDF - MB) | Clinical pharmacology (PDF - 5 MB) | Statistical (PDF - 3 MB) | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF -138 KB) | None | PREA |
| Rilpivirine - Edurant | Janssen Products L.P. | Medical (PDF - 41 MB) | Clinical pharmacology (PDF - 2 MB)
Clinical pharmacology (PDF - 235 KB) | | PREA |
| Rilpivirine - Edurant | Janssen Products, LP | Medical (PDF - 9 MB) | None | None | BOTH |
| Rivaroxaban - Xarelto | Janssen Pharmaceuticals, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 10 MB) | Statistical (PDF - 797 KB) | BOTH |
| Risperidone - Risperdal Consta | Janssen Pharmaceuticals, Inc. | DD Summary Review (PDF - 20 KB)
CTDL Review (PDF - 1 MB)
Medical (PDF - 670KB)
Medical (PDF - 667 KB) | None | Statistical (PDF - 237 KB) | PREA |
| Ritlecitinib - Litfulo | Pfizer, Inc. | Medical (PDF - 15 MB) | None | None | PREA |
| Rituximab-arrx - Riabni | Amgen, Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Rizatriptan - RizaFilm | IntelGenx Corp. | Medical (PDF - 352 KB)
Memo (PDF - 851 KB) | Clinical pharmacology (PDF - 220 KB) | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 5 MB) | Clinical pharmacolog y (PDF - 3 MB) | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Roflumilast - Zoryve | Arcutis Biotherapeutics, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Rosuvastatin - Ezallor Sprinkle | Sun Pharmaceutical Industries Limited | Medical (PDF - 27 KB) | None | None | PREA |
| Rosuvastatin and ezetimibe - Roszet | Althera Pharmaceuticals, LLC. | Medical (PDF - 187 KB) | None | None | PREA |
| Rufinamide - Banzel | Eisai Inc. | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 3 MB) | None | BPCA |
| Ruxolitinib - Jakafi | Incyte Corporation | Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | None | BPCA |
| Ruxolitinib - Jakafi | Incyte Corporation | Medical (PDF - 685 KB) | None | None | BPCA |
| Ruxolitinib - Opzelura | Incyte Corporation | Medical (PDF - 9 MB) | None | None | PREA |
| Ruxolitinib - Opzelura | Incyte Corporation | Medical (PDF - 7 MB) | None | None | PREA |
| Ruxolitinib - Opzelura | Incyte Corporation | Medical (PDF - 4 MB) | None | None | PREA |
| Sacubitril-valsartan - Entresto | Novartis Pharmaceuticals Corp. | Medical (PDF - 685 KB) | Clinical pharmacology (PDF - 533 KB) | Statistical (PDF - 1 MB) | BPCA |
| Sacubitril-valsartan - Entresto | Novartis Pharmaceuticals Corp. | CDTL (PDF - 727 KB)
Medical (PDF - 9 MB) | Clinical pharmacology (PDF - 6 MB) | None | PREA |
| Sapropterin dihydrochloride - Kuvan | BioMarin Pharmaceutical Inc. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 3 MB) | None | BPCA |
| Saquinavir mesylate - Invirase | Hoffmann La-Roche, Inc.orporated c/o Genentech, Inc. | Medical (PDF -1 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 1 MB) | BOTH |
| Sarecycline - Seysara | Allergan, Inc. | Medical (PDF -1 MB) | None | None | PREA |
| Sarilumab- Kevzara | Sanofi US Services Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Saxagliptin and metformin hydrochloride - Kombiglyze XR | AstraZeneca AB | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 8 MB)
Clinical pharmacology memo (PDF - 8 MB) | Statistical (PDF - 1 MB) | PREA |
| Saxagliptin - Onglyza | AstraZeneca AB | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 8 MB)
Clinical pharmacology memo (PDF - 8 MB) | Statistical (PDF - 1 MB) | PREA |
| Secnidazole - Solosec | Lupin Pharmaceuticals, Inc. | Medical (PDF 4 MB) | None | None | PREA |
| Secnidazole - Solosec | Lupin Pharmaceuticals, Inc. (A subsidiary of Lupin Inc.) | Medical (PDF 2 MB) | None | None | PREA |
| Secukinuma - Cosentyx | Novartis Pharmaceuticals Corporation | Medical (PDF - 6 MB) | None | None | PREA |
| Selegiline - Emsam | Somerset Pharmaceuticals | Medical (PDF - 1 MB)
Medical 2 (PDF - 1 MB)
Medical Secondary 1 (PDF - 349 KB)
Medical Secondary 2 (PDF - 188 KB) | None | None | PREA |
| Selenious Acid - Selenious Acid | American Regent, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Selenious Acid - Selenious Acid | American Regent, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Selpercatinib - RETEVMO | Eli Lilly and Company | Medical (PDF - 869 KB) | Clinical pharmacology (PDF - 16 MB) | Statistical (PDF - 869 KB) | BPCA |
| Segesterone acetate and ethinyl estradiol vaginal systems - Annovera | The Population Council, Inc. | Medical (PDF - 5 MB) | None | None | PREA |
| Semaglutide - Wegovy | Novo Nordisk Inc. | Medical (PDF - 8 MB) | Clinical pharmacology (PDF - 16 MB) | Statistical (PDF - 869 KB) | PREA |
| Semaglutide - Wegovy | Novo Nordisk Inc. | CDTL (PDF - 721 KB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Serdexmethylphenidate and dexmethylphenidate - Azstarys | Commave Therapeutics | Multidisciplinary (PDF - 7 MB) | None | None | PREA |
| Sevelamer Carbonate - Renvela | Genzyme/Sanofi | Medical (PDF - 745 KB) | Clinical pharmacology (PDF - 542 KB) | Statistical (PDF - 541KB) | PREA |
| Sitagliptin - Januvia, Janumet & Janumet XR | Merck Sharp & Dohme Corp.: | CDTL (PDF - 1 MB)
Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 339 KB) | Statistical (PDF - 623 KB) | BOTH |
| Sildenafil - Revatio | Pfizer, Inc. | Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 508 KB) | BOTH |
| Sodium oxybate - Xyrem | Jazz Pharmaceuticals | Medical (PDF - 193 KB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 508 KB) | BPCA |
| Sodium phenylbutyrate - Olpruva | Acer Therapeutics Inc. | Medical (PDF - 24 KB) | None | None | PREA |
| Sodium picosulfate, magnesium oxide, and anhydrous citric acid - Prepopik | Ferring Pharmaceuticals Inc. | CDTL (PDF - 1 MB) | None | None | PREA |
| Sodium sulfate, potassium sulfate, and magnesium sulfate - Suprep Bowel Prep Kit | Braintree Laboratories, Inc. | Medical (PDF - 193 KB) | None | None | PREA |
| Sodium picosulfate, magnesium oxide and anhydrous citric acid - Clenpiq | Ferring Pharmaceuticals Inc. | Medical (PDF - 193 KB) | None | None | PREA |
| Sofpironium - Sofdra | Botanix SB Inc. | Unireview (PDF - 4 MB)
Medical (PDF - 133 KB) | None | None | PREA |
| Spinosad - Natroba | ParaPRO, LLC | Medical (PDF - 854 KB) | Clinical pharmacology (PDF - 171 KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical and CDTL (PDF - 345 KB) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir - Sovaldi | Gilead Sciences, Inc. | Medical (PDF - 218 KB) | None | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 218 KB) | Clinical pharmacology (PDF - 511 KB) | None | PREA |
| Sofosbuvir and velpatasvir - Epclusa | Gilead Sciences, Inc. | Medical (PDF - 287 KB) | Clinical pharmacology (PDF - 4 MB) | None | BOTH |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 933 KB) | Statistical PDF - 960 KB) | BOTH |
| Solifenacin succinate - VESIcare | Astellas Pharma Global Development, Inc. | Medical (PDF - 3 MB)
CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 960 KB) | BOTH |
| Spinosad - Natroba | ParaPRO LLC | Medical (PDF - 458 KB) | None | None | PREA |
| Sucroferric oxyhydroxide - Velphoro | Vifor Fresenius Medical Care Renal Pharma France | Medical (PDF - 1 MB)
CDTL (PDF - 1 MB)
Multidisciplinary (PDF - 1 MB) | None | None | PREA |
| Sugammadex - Bridion | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Medical (PDF - 3 MB | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 2 MB) | PREA |
| Sugammadex - Bridion | Merck Sharp & Dohme LLC | CDTL (PDF - 2 MB) | Clinical pharmacology (PDF - 612 KB)
Clinical pharmacology correction (PDF - 612 KB) | Statistical (PDF - 509 KB) | BOTH |
| Sulfur Hexafluoride Lipid-Type A Microspheres) for Injectable Suspension - Lumason | Bracco Diagnostics Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 792 KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF - 3 MB)
CDTL (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 859 KB) | PREA |
| Sulfur Hexafluoride Lipid-Type A Microspheres - Lumason | Bracco Diagnostics, Inc. | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 843 KB) | PREA |
| Sumatriptan/Naproxen - Treximet | Pernix Therapeutics | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -843 KB)
Statistical Addendum (PDF - 702 KB) | BOTH |
| Sunitinib malate - Sutent | C.P. Pharmaceuticals International C.V. | CDTL (PDF - 680 KB) | None | None | BPCA |
| Tacrolimus - Astagraf XL | Astellas Pharma US, Inc. | Medical (PDF - 749 KB) | None | None | PREA |
| Tadalafil - Cialis | Eli Lilly and Company | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 1 MB) | None | BPCA |
| Tapentadol - Nucynta | Collegium Pharmaceutical, Inc. | CDTL - DD (PDF - 9 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF -700 KB) | PREA |
| Tapentadol - Nucynta | Collegium Pharmaceutical, Inc. | Medical (PDF - 1 MB) | None | None | BPCA |
| Tavaborole - Kerydin | Anacor Pharmaceuticals, Inc. | Multi-disciplinary review (PDF - 3 MB) | None | None | BOTH |
| Tazarotene - Arazlo | Bausch Health US, LLC | Clinical (PDF - 1 MB) | None | None | PREA |
| Tbo-filgrastim - Granix | Sicor Biotech UAB c/o Teva Branded Pharmaceutical Products R&D | CDTL (PDF - 176 KB)
Clinical (PDF - 196 KB) | Clinical pharmacology (PDF - 434 KB) | None | BOTH |
| Technetium 99m Tilmanocept - Lymphoseek | Cardinal Health 414, LLC | Multidisciplinary (PDF - 2 MB) | None | None | PREA |
| Kit for the Preparation of Technetium Tc 99m Succimer Injection -NephroScan | Theragnostics Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Tedizolid phosphate - Sivextro | Cubist Pharmaceuticals, LLC | Medical (PDF - 9 MB) | None | None | PREA |
| Tedizolid phosphate - Sivextro | Cubist Pharmaceuticals LLC | Medical (PDF - 9 MB) | None | None | PREA |
| Teduglutide - Gattex | Shire-NPS Pharmaceuticals, Inc. | Medical (PDF - 9 MB) | None | None | PREA |
| Tenofovir alafenamide - Vemlidy | Gilead Sciences, Inc | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 624 KB) | PREA |
| Tenofovir alafenamide - Vemlidy | Gilead Sciences, Inc | Medical (PDF - 3 MB) | None | None | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | Medical (PDF - 2 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 1 MB) | PREA |
| Tenofovir disoproxil fumarate - Viread | Gilead Sciences | CDTL (PDF - 873 KB) | Clinical pharmacology (PDF - 180 KB) | Statistical (PDF - 149 KB) | BOTH |
| Teriflunomide - Aubagio | Sanofi | CTDL (PDF - 3 MB)
Clinical (PDF - 3 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 410 KB) | BOTH |
| Tetracaine hydrochloride - Steri-Unit | Alcon Research, Ltd. | DD Medical Summary (PDF - 2 MB)
Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 158 KB) | Statistical (PDF - 2 MB) | PREA |
| Tetracaine HCl and Oxymetazoline HCl - Kovanaze | St. Renatus, LLC | Medical (PDF - 12 MB) | Clinical pharmacology (PDF - 11 MB) | Statistical (PDF - 2 MB) | PREA |
| Tezepelumab -Tezspir | AstraZeneca | Medical (PDF - 10 MB) | None | None | PREA |
| Ticagrelor - Brilinta | AstraZeneca Pharmaceuticals LP | Medical (PDF - 10 MB) | Clinical pharmacology (PDF - 1 MB) | Statistical (PDF - 325 KB) | BPCA |
| Tilmanocept - Lymphoseek | Cardinal Health 414, LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 12 MB)
Medical Addendum (PDF - 418 KB | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 1 MB)
Statistical Addendum (PDF - 327 KB) | PREA |
| Tiotropium bromide - Spiriva Respimat | Boehringer Ingelheim Pharmaceuticals, Inc. | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 432 KB) | BOTH |
| Tirzepatide - Mounjaro NEW | Eli Lilly and Company | Medical (PDF - 5 MB) | None | None | BOTH |
| Tobramycin 300 mg/4mL inhalation solution - Bethkis | Cornerstone Therapeutics | Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 78 KB) | Statistical (PDF - 687 KB) | PREA |
| Tocilizumab - Actemra | Genentech, Inc. | Medical (PDF - 72 KB)
Medical (PDF - 109 KB) | Clinical pharmacology (PDF - 195 KB) | None | PREA |
| Tocilizumab - Actemra | Genentech, Inc. | Medical (PDF - 8 MB) | None | None | BOTH |
| Tocilizumab - Actemra | Genentech, Inc. | Medical (PDF - 7 MB) | None | None | PREA |
| Tocilizumab-anoh - Avtozma | CELLTRION, Inc. | Medical (PDF - 576 KB) | None | None | PREA |
| Tocilizumab-bavi - Tofidence | Biogen MA Inc | Medical (PDF - 5 MB) | None | None | PREA |
| Tocilizumab-aazg -Tyenne | Fresenius Kabi USA, LLC | CDTL (PDF - 42 KB)
Medical (PDF - 8 MB) | None | None | PREA |
| Tofacitinib - Xeljanz | Pfizer, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Tofacitinib - Xeljanz | Pfizer, Inc. | Medical (PDF - 1 MB) | Clinical pharmacology (PDF - 168 KB) | None | BPCA |
| Topiramate - Topamax | Janssen Pharmaceuticals, Inc. | Medical (PDF - 8 MB) | None | Statistical (PDF - 881 KB) | PREA |
| Topiramate - Eprontia | Azurity Pharmaceuticals, Inc. | Medical (PDF - 669 KB) | Clinical pharmacology (PDF - 565 KB) | None | PREA |
| Trabectedin - Yondelis | Janssen Products, LP | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 683 KB) | None | BPCA |
| Trace elements injection 4 - Tralement | American Regent, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Trace elements injection 4 - Tralement | American Regent, Inc. | Medical (PDF - 321 KB) | None | None | PREA |
| Tralokinumab-ldrm - Adbry | LEO Pharma A/S c/o LEO Pharma Inc | Unireview (PDF - 4 MB)
Medical (PDF - 32 KB) | None | None | PREA |
| Trametinib - Mekinist | Novartis Pharmaceuticals Corporation | Medical (PDF - 18 MB) | None | None | PREA |
| Trametinib - Mekinist | Novartis Pharmaceuticals Corporation | Medical (PDF - 800 KB) | Clinical pharmacology (PDF - 616 KB) | None | BPCA |
| Tranexamic acid - Lysteda | Ferring Pharmaceuticals, Inc. | None | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Tremelimumab-actl - Imjudo | AstraZeneca AB | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 1 MB) | None | PREA |
| Tretinoin lotion - Altreno | Dow Pharmaceutical Sciences, Inc. | Medical (PDF - 3 MB) | None | None | PREA |
| Tretinoin and benzoyl peroxide - Twyneo | Sol-Gel Technologies Ltd. c/o B&H Consulting Services Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Trifarotene - Aklief | Galderma Research and Development | Medical (PDF - 3 MB) | None | None | PREA |
| Trofinetide - Daybue | Acadia Pharmaceuticals Inc | Medical (PDF - 212 KB)
Medical (PDF - 6 MB) | Clinical pharmacology (PDF - 6 MB) | Statistical (PDF - 2 MB)
Statistical Errata (PDF - 28 KB) | BPCA |
| Tropicamide and phenylephrine - MYDCOMBI | Eyenovia, Inc. | CDTL - DD (PDF - 6 MB) | None | Statistical (PDF - 2 MB) | PREA |
| Upadacitinib - Rinvoq | AbbVie Inc. | Medical (PDF - 10 MB) | None | None | PREA |
| Upadacitinib - Rinvoq and Rinvoq LQ | AbbVie Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ustekinumab-aauz - Otulfi | Fresenius Kabi USA, LLC | Medical (PDF - 558 KB) | None | None | PREA |
| Ustekinumab-aekn - Selarsdi | Alvotech USA Inc | CDTL (PDF - 178 KB)
Medical (PDF - 507 KB) | None | None | PREA |
| Ustekinumab-srlf - Imuldosa | Accord BioPharma, Inc. | Medical (PDF - 6 MB) | None | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech, Inc. | Medical (PDF - 352 MB) | Clinical pharmacology (PDF - 3 MB) | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech, Inc. | Medical (PDF - 8 MB) | None | None | PREA |
| Ustekinumab - Stelara | Janssen Biotech Inc. | CDTL (PDF - 593 KB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 3 MB) | Statistical (PDF - 275 KB) | PREA |
| Ustekinumab-stba - Steqeyma | CELLTRION, Inc. | Medical (PDF - 29 MB) | None | None | PREA |
| Ustekinumab-aekn - Selarsdi | Alvotech USA Inc. PharmaLex US Corporation | CDTL (PDF - 123 KB)
Medical (PDF - 5 MB) | Clinical pharmacology (PDF - 9 KB) | None | PREA |
| Valganciclovir hydrochloride - Valcyte | Roche Palo Alto LLC c/o Genentech, Incorporated | Medical (PDF - 3 MB) | Clinical pharmacology (PDF - 6 MB) | None | PREA |
| Valsartan - Diovan | Novartis Pharmaceuticals Corporation | Medical (PDF - 2 MB) | None | None | PREA |
| Varenicline - Chantix | PF Prism C V | Multidisciplinary review (PDF - 3 MB) | None | None | BOTH |
| Vigabatrin - Sabril | Lundbeck LLC. | Medical (PDF - 4 MB) | Clinical pharmacology (PDF - 2 MB) | Statistical (PDF - 698 KB) | BOTH |
| Vilazodone hydrochloride - Viibryd | Allergan Sales, LLC | Medical (PDF - 3 MB) | None | None | BOTH |
| Viloxazine extended release capsules - Qelbree | Supernus Pharmaceuticals, Inc. | Medical (PDF - 13 KB)
Medical (PDF - 13 MB) | None | None | PREA |
| Viloxazine extended-release capsules - Qelbree | Supernus Pharmaceuticals, Inc. | Medical (PDF - 2 MB) | None | None | PREA |
| Vortioxetine - Trintellix | Takeda Pharmaceuticals, USA, Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Vortioxetine - Trintellix | Takeda Pharmaceuticals, USA, Inc. | Medical (PDF - 3 MB) | None | None | BOTH |
| Voriconazole - Vend | PF PRISM C.V. | Medical (PDF - 2 MB)
Medical PDF - 200 KB) | Clinical Pharmacology (PDF - 1 MB) | Statistical (PDF - 200 KB) | PREA |
| Xenon Xe 129 hyperpolarized - Xenoview | Polarean Inc. | Medical PDF - 200 KB) | None | None | PREA |
| Xenon Xe 129 hyperpolarized - Xenoview | Polarean Inc. | CDTL (PDF - 200 KB) | Clinical Pharmacology (PDF - 1 MB) | None | PREA |
| Zinc sulfate - None | American Regent, Inc. | Medical (PDF - 4 MB) | None | None | PREA |
| Ziprasidone - Geodon | Viatris Specialty LLC | Medical (PDF - 2 MB) | None | None | PREA |
| Zoliflodacin - Nuzolvence | Entasis Therapeutics, Inc. | Medical (PDF - 9 MB) | None | None | PREA |
| Zolmitriptan - Zomig | AstraZeneca Pharmaceuticals LP | Medical (PDF - 5 MB) | None | Statistical (PDF - 3 MB) | PREA |
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
- ## Content current as of:
04/27/2026
Regulated Product(s)
- Drugs
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