FDA Untitled Letters to Pharmaceutical Companies
Summary
The FDA's CDER Freedom of Information Office has published a list of 34 untitled letters issued to pharmaceutical companies between February 2026 and September 2025. These letters address promotional communications for various prescription drugs, indicating potential violations of FDA regulations regarding drug advertising and promotion.
What changed
The FDA has released a compilation of 34 untitled letters issued by the Office of Prescription Drug Promotion (OPDP) to pharmaceutical companies. These letters, dated from late 2025 through early 2026, address specific promotional communications for various prescription drugs, including OZEMPIC®, TREMFYA®, VYVGART HYTRULO®, and others. The untitled letters signify that the FDA has identified potential violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of these drugs.
Pharmaceutical companies receiving these letters must review their promotional materials and ensure compliance with FDA regulations. While untitled letters do not carry the same weight as warning letters, they indicate a need for immediate corrective action to prevent further violations. Companies should verify that their marketing and promotional activities accurately represent the drug's benefits and risks, and do not make unsubstantiated claims. Failure to address the concerns raised in these letters could lead to more severe enforcement actions, such as warning letters or other penalties.
What to do next
- Review promotional materials for compliance with FDA regulations
- Ensure marketing claims accurately reflect drug benefits and risks
- Address any identified violations promptly to avoid further enforcement
Archived snapshot
Mar 23, 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.
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters. The agency may have redacted or edited some of the letters to remove confidential information.
1997-2016 Compliance Actions are archived. To view them, please see the FDA Archive.
To view OPDP Warning Letters, please see Warning Letters.
Office of Prescription Drug Promotion Untitled Letters and Corresponding Promotional Communications
| Issued Date | Company / Individual | Product / Issue | Response Letter | Close-Out Letter |
|---|---|---|---|---|
| 2/26/2026 | Novo Nordisk Inc. |
Untitled Letter (PDF) | OZEMPIC® (semaglutide) injection, for subcutaneous use | | |
| 2/6/2026 | Janssen Biotech, Inc.Untitled Letter (PDF) | TREMFYA® (guselkumab) injection, for subcutaneous or intravenous use | | |
| 2/6/2026 | Sobi, Inc.Untitled Letter (PDF) | VONJO® (pacritinib) capsules, for oral use | | Close-Out Letter
(PDF) |
| 2/5/2026 | Novo Nordisk Inc.Untitled Letter (PDF) | WEGOVY® (semaglutide) tablets, for oral use | | |
| 1/30/2026 | argenx US, Inc.Untitled Letter (PDF) | VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use | | |
| 1/30/2026 | argenx US, Inc.Untitled Letter (PDF) | VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc) injection, for subcutaneous use | | |
| 1/23/2026 | ARS Pharmaceutical Operations, Inc.Untitled Letter (PDF) | NEFFY® (epinephrine nasal spray) | None | |
| 1/7/2026 | Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)Untitled Letter (PDF)
Promotional Material (PDF) | ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use | None | Close-Out Letter
(PDF) |
| 1/7/2026 | BeOne Medicines USA, Inc.Untitled Letter (PDF) | BRUKINSA® (zanubrutinib) capsules and tablets, for oral use | None | Close-Out Letter
(PDF) |
| 12/19/2025 | Esperion Therapeutics, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NEXLIZET® (bempedoic acid and ezetimibe) tablets, for oral use | None | Close-Out Letter (PDF) |
| 12/15/2025 | BeOne Medicines USA, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | TEVIMBRA® (tislelizumab-jsgr) injection, for intravenous use | None | Close-Out Letter
(PDF) |
| 12/15/2025 | Karuna Therapeutics, Inc., a Bristol Myers Squibb Co.Untitled Letter (PDF) | COBENFY™ (xanomeline and trospium chloride) capsules, for oral use | None | |
| 11/24/2025 | Daiichi Sankyo, Inc.Untitled Letter (PDF) | TURALIO® (pexidartinib) capsules, for oral use | None | Close-Out Letter
(PDF) |
| 9/9/2025 | GlaxoSmithKline LLCUntitled Letter (PDF)
Promotional Material (PDF) | NDA 215499 APRETUDE (cabotegravir extended-release injectable suspension), for intramuscular use | None | Close-Out Letter
(PDF) |
| 9/30/2025 | SK Life Science, Inc.Untitled Letter (PDF) | Xcopri® (cenobamate tablets) for oral use, CV | None | |
| 9/30/2025 | PharmaTher Inc.Untitled Letter (PDF)
Promotional Material (PDF) | ANDA 217858 KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CII MA 2 | None | Close-Out Letter
(PDF) |
| 9/23/2025 | AstraZenecaUntitled Letter (PDF) | FARXIGA® (dapagliflozin) tablets, for oral use | None | Close-Out Letter
(PDF) |
| 9/9/2025 | Aadi BioscienceUntitled Letter (PDF)
Promotional Material (PDF) | FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albuminbound), for intravenous use | None | Close-Out Letter (PDF) |
| 9/23/2025 | Novartis Pharmaceuticals CorporationUntitled Letter (PDF)
Promotional Material (PDF) | FABHALTA® (iptacopan) capsules, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Altor BioScience, LLC, (an indirect wholly-owned subsidiary of ImmunityBio, Inc.)Untitled Letter (PDF)
Promotional Material (PDF) | ANKTIVA® (nogapendekin alfa inbakicept-pmln) solution, for intravesical use | None | Close-Out Letter
(PDF) |
| 9/9/2025 | Takeda Pharmaceuticals America, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | ICLUSIG® (ponatinib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Amgen Inc.Untitled Letter (PDF) | IMDELLTRA™ (tarlatamab-dlle) for injection, for intravenous use | None | |
| 9/9/2025 | Evolus, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | JEUVEAU® (prabotulinumtoxinA-xvfs) for injection, for intramuscular use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Incyte CorporationUntitled Letter (PDF)
Promotional Material (PDF) | PEMAZYRE® (pemigatinib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Pinnacle Biologics, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | PHOTOFRIN® (porfimer sodium) for injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Pinnacle Biologics, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | PHOTOFRIN® (porfimer sodium) for injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | UCB, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | RYSTIGGO® (rozanolixizumab-noli) injection, for subcutaneous use | None | |
| 9/9/2025 | AbbVie, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | SKYRIZI® (risankizumab-rzaa) injection, for subcutaneous or intravenous   use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Ipsen Biopharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | TAZVERIK® (tazemetostat) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Alnylam Pharmaceuticals, Inc.Untitled Letter (PDF) | AMVUTTRA® (vutrisiran) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | BridgeBio Pharma, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | ATTRUBY® (acoramidis) tablets | None | Close-Out Letter (PDF) |
| 9/9/2025 | Teva Neuroscience, Inc.Untitled Letter (PDF) | AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use | None | |
| 9/9/2025 | Teva Neuroscience, Inc.Untitled Letter (PDF) | AUSTEDO® XR (deutetrabenazine) extended-release tablets, for oral use | None | |
| 9/9/2025 | Axsome Therapeutics, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | AUVELITY® (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | UCB, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | UCB, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | UCB, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | AstraZeneca Pharmaceuticals LPUntitled Letter (PDF)
Promotional Material (PDF) | CALQUENCE® (acalabrutinib) capsules, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Bristol Myers SquibbUntitled Letter (PDF)
Promotional Material (PDF) | CAMZYOS® (mavacamten) capsules for oral use | None | |
| 9/9/2025 | Nalpropion Pharmaceuticals, LLCUntitled Letter (PDF)
Promotional Material (PDF) | CONTRAVE (naltrexone hydrochloride and bupropion hydrochloride) extended release tablets, for oral use | None | |
| 9/9/2025 | Azurity Pharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | DANZITEN (nilotinib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | AstraZeneca Pharmaceuticals LPUntitled Letter (PDF)
Promotional Material (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | AstraZeneca Pharmaceuticals LPUntitled Letter (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | AstraZeneca Pharmaceuticals LPUntitled Letter (PDF) | FASENRA® (benralizumab) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Takeda Pharmaceuticals USA, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | FRUZAQLA® (fruquintinib) capsules, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Takeda Pharmaceuticals USA, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | FRUZAQLA® (fruquintinib) capsules, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Neurocrine Biosciences, IncUntitled Letter (PDF)
Promotional Material (PDF) | INGREZZA® (valbenazine) capsules, for oral use | None | |
| 9/9/2025 | Novartis Pharmaceuticals CorporationUntitled Letter (PDF)
Promotional Material (PDF) | KESIMPTA® (ofatumumab) injection, for subcutaneous use | None | |
| 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc.Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc.Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Boehringer Ingelheim Pharmaceuticals, Inc.Untitled Letter (PDF) | JARDIANCE® (empagliflozin tablets), for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Bausch Health Companies Inc.Untitled Letter (PDF)
Promotional Material (PDF) | JUBLIA® (efinaconazole) topical solution, 10% for topical use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Novartis Pharmaceuticals CorporationUntitled Letter (PDF)
Promotional Material (PDF) | KISQALI® (ribociclib) tablets, for oral use | None | |
| 9/9/2025 | AbbVie, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | LINZESS® (linaclotide) capsules, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | ARS Pharmaceutical Operations, Inc.Untitled Letter (PDF) | NEFFY® (epinephrine nasal spray) | None | |
| 9/9/2025 | Galderma Laboratories, L.P.Untitled Letter (PDF) | NEMLUVIO® (nemolizumab-ilto) for injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Bristol-Myers SquibbUntitled Letter (PDF) | OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Bristol-Myers SquibbUntitled Letter (PDF) | OPDIVO® (nivolumab) injection, for intravenous use
YERVOY® (ipilimumab) injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Supernus Pharmaceuticals, Inc.
- Untitled Letter (PDF)
Promotional Material (PDF) | QELBREE® (viloxazine extended-release capsules), for oral use | None | |
| 9/9/2025 | Supernus Pharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | QELBREE® (viloxazine extended-release capsules), for oral use | None | |
| 9/9/2025 | AbbVie, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | QULIPTA® (atogepant) tablets, for oral use | None | |
| 9/9/2025 | Novartis Pharmaceuticals CorporationUntitled Letter (PDF)
Promotional Material (PDF) | PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | AstraZeneca Pharmaceuticals LPUntitled Letter (PDF) | TRUQAP® (capivasertib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | SanofiUntitled Letter (PDF) | TZIELD® (teplizumab-mzwv) injection, for intravenous use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Pfizer, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | VELSIPITY™ (etrasimod) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Phathom Pharmaceuticals, Inc.Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Phathom Pharmaceuticals, Inc.Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Phathom Pharmaceuticals, Inc.Untitled Letter (PDF) | VOQUEZNA (vonoprazan) tablets, for oral use | None | Close-Out Letter (PDF) |
| 9/9/2025 | Alexion Pharmaceuticals, Inc.Untitled Letter (PDF) | ULTOMIRIS® (ravulizumab-cwvz) injection, for intravenous use | None | |
| 4/28/2025 | Mayne Pharma LLCUntitled Letter (PDF)
Promotional Material (PDF) | NEXTSTELLIS
(drospirenone and estetrol tablets), for oral use | None | Close-Out Letter (PDF) |
| 3/21/2025 | Taiho Oncology, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 214801, LYTGOBI (futibatinib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 2/3/2025 | Edenbridge DBA DexcelUntitled Letter (PDF)
Promotional Material (PDF) | NDA 211379, HEMADY
(dexamethasone tablets), for oral use | None | Close-Out Letter (PDF) |
| 10/31/2024 | Merz Pharmaceuticals GmbHUntitled Letter (PDF)
Promotional Material (MP4 | Duration: 1min 14sec ) | BLA 125360 XEOMIN
(incobotulinumtoxinA) for injection, for intramuscular or intraglandular use | None | Close-Out Letter (PDF) |
| 8/29/2024 | AbbVie, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 211765, UBRELVY (ubrogepant) tablets, for oral use | None | Close-Out Letter (PDF) |
| 8/1/2024 | Mirati Therapeutics Inc., a Bristol Myers Squibb Co.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 216340, KRAZATI™ (adagrasib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 7/17/2024 | Kaleo, Inc.Untitled Letter (PDF)
Promotional Material (PDF)
Promotional Material (MP4 | Duration: 40sec) | NDA 201739, AUVI-Q (epinephrine injection, USP), for intramuscular or subcutaneous use | None | Close-Out Letter (PDF) |
| 1/18/2024 | Novartis Pharmaceuticals CorporationUntitled Letter (PDF)
Promotional Material (PDF) | NDA 209092
KISQALI (ribociclib) tablets, for oral use | None | Close-Out Letter (PDF) |
| 10/31/2023 | Otsuka Pharmaceutical Development and Commercialization, IncUntitled Letter (PDF)
Promotional Material (PDF)
Promotional Material (PDF) | NDA 205422 REXULTI (brexpiprazole) tablets, for oral use | None | Close-Out Letter (PDF) |
| 10/31/2023 | Evofem BiosciencesUntitled Letter (PDF)
Promotional Material (PDF) | NDA 208352 PHEXXI (lactic acid, citric acid, and potassium bitartrate) vaginal gel | None | Close-Out Letter (PDF) |
| 6/07/2023 | Xeris Pharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 214133 RECORLEV (levoketoconazole) tablets, oral | None | Close-Out Letter (PDF) |
| 8/11/2023 | Exeltis USA Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 211367 SLYND (drospirenone) tablets, oral | None | Close-Out Letter (PDF) |
| 01/19/2022 | Eli Lilly & CompanyUntitled Letter (PDF)
Promotional Material (PDF) | BLA 125469 TRULICITY® (dulaglutide) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 3/31/2022 | Bausch Health Companies IncUntitled Letter (PDF)
Promotional Material (PDF)
Promotional Material (PDF) | NDA 209354 DUOBRII (halobetasol propionate and tazarotene) lotion, for topical use | None | Close-Out Letter (PDF) |
| 6/02/2022 | Althera PharmaceuticalsUntitled Letter (PDF)
Promotional Material (PDF) | NDA 213072 ROSZET (rosuvastatin ezetimibe) tables, for oral use | None | Close-Out Letter (PDF) |
| 12/13/2021 | EmgalityUntitled Letter (PDF) | BLA 761063 EMGALITY (galcanezumab-gnlm) injection, for subcutaneous use | Response Letter (PDF) | Close-Out Letter (PDF) |
| 8/09/2021 | Alkindi SprinkleUntitled Letter (PDF)
Promotional Material (PDF) | NDA 213876 ALKINDI® SPRINKLE (hydrocortisone) oral granules | None | Close-Out Letter (PDF) |
| 7/07/2021 | AmgenUntitled Letter (PDF)
Promotional Material (PDF) | BLA 125031 NEULASTA® (pegfilgrastim) injection, for subcutaneous use | None | Close-Out Letter (PDF) |
| 3/08/2021 | Biohaven PharmaceuticalsUntitled Letter (PDF) | NDA 212728Â NURTEC ODT (rimegepant) orally disintegrating tablets, for sublingual or oral use | None | Close-Out Letter (PDF) |
| 11/24/2020 | Azurity Pharmaceuticals Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 208400 XATMEP® (methotrexate) oral solution | None | None |
| 8/14/2020 | Xeris Pharmaceuticals, Inc.Untitled Letter (PDF) | NDA 212097Â GVOKETM (glucagon) injection, for subcutaneous use | None | None |
| 11/18/2019 | Rockwell Medical, IncUntitled Letter (PDF)
Promotional Material (PDF) | NDA 206317; NDA 208551 TRIFERIC (ferric pyrophosphate citrate) solution and TRIFERIC® (ferric pyrophosphate citrate) powder packet for addition to bicarbonate concentration | None | None |
| 11/01/2019 | Nascent Biotech, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | Pritumumab | None | None |
| 9/24/2019 | Kowa Pharmaceuticals, Inc.Untitled Letter (PDF) | NDA 022363 Livalo (pitavastatin) tablet, for oral use | None | None |
| 7/25/2019 | CooperSurgical, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 018680 ParaGard T380A Intrauterine Copper Contraceptive | None | None |
| 6/14/2019 | Aclaris Therapeutics, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 209305 ESKATA (hydrogen peroxide) topical solution | None | None |
| 5/22/2019 | VIVUS, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 022580 QSYMIA (phentermine and topiramate extended-release) capsules, for oral use, CIV | None | None |
| 2/15/2019 | Phoenix Molecular Imaging CenterUntitled Letter (PDF)
Promotional Material (PDF) | Sodium Acetate (C-11) | None | None |
| 10/11/2018 | Eisai Inc.Untitled Letter (PDF) | - NDA 202834; 208277
Fycompa (perampanel) oral suspension, CIII
Fycompa(perampanel) tablets, for oral use, CIII | None | None |
| 8/16/2018 | ASCEND Therapeutics US, LLCUntitled Letter (PDF)
Promotional Material (PDF) | NDA 021166 EstroGel 0.06% (estradiol gel) for topical use | None | None |
| 6/28/2018 | Arog Pharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | Crenolanib besylate | None | None |
| 6/19/2018 | Pfizer Inc.Untitled Letter (PDF) | NDA 020472 ESTRING® (estradiol vaginal ring) | None | None |
| 2/09/2018 | Collegium Pharmaceuticals, Inc.Untitled Letter (PDF)
Promotional Material (PDF) | NDA 208090 Xtampza ER (oxycodone) extended-release capsules, for oral use | None | None |
| 12/28/2017 | University of California Los Angeles (UCLA)Untitled Letter (PDF)
Promotional Material (PDF) | Gallium 68 (68GA-PSMA) (Prostate Cancer Imaging webpage and brochure) | None | None |
| 5/18/2017 | Orexigen Therapeutics, Inc.Promotional Material (PDF) | NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets | None | None |
- ## Content current as of:
03/10/2026
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- Drugs
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