FDA Drugs@FDA - New Applications and Actions

FDA Approves FOUNDAYO Orforglipron Type 1 New Molecular Entity

FDA approved NDA 220934 for FOUNDAYO (orforglipron calcium), a Type 1 new molecular entity, on April 1, 2026. The drug is approved in six strengths (0.8mg, 2.5mg, 5.5mg, 9mg, 14.5mg, and 17.2mg base equivalents) as an oral tablet for prescription use. Eli Lilly and Company holds the approved NDA, with the 17.2mg strength designated as the reference standard (RS).

Semaglutide ANDA 220314 Tentative Approval, Apotex

FDA has issued a Tentative Approval for ANDA #220314 filed by Apotex Inc., covering five semaglutide injection formulations in varying strengths (2.68 mg/mL, 2 mg/1.5 mL, 2 mg/3 mL, 4 mg/3 mL, and 8 mg/3 mL). Tentative Approval indicates the application meets FDA requirements for safety, efficacy, and quality, but marketing cannot begin because of existing patent or exclusivity protections on the reference listed drug. No Marketing Status, TE Code, RLD, or RS designation has been assigned.

Merck NDA 216964 IDVYNSOTM Doravirine Islatravir Combo Approved

The FDA approved New Drug Application (NDA) 216964 filed by Merck Sharp and Dohme LLC for IDVYNSOTM, a fixed-dose combination product containing Doravirine (100MG) and Islatravir (0.25MG) in tablet form for oral administration. The product received Prescription marketing status, making it available for clinical use. This approval represents a new antiretroviral combination therapy option for patients requiring HIV treatment.