Drugs
FDA Approval Records
FDA-approved drugs, each with what the agency's own reviews say about the decision, the evidence, safety and post-approval requirements, quoted and linked to the documents.
Alzheimer's disease
| Drug | Sponsor | Application | FDA action | Date |
|---|---|---|---|---|
| Kisunla (donanemab) | Eli Lilly and Company | BLA 761248 | Approved | Jul 2, 2024 |
| Leqembi (lecanemab) | Eisai | BLA 761269 | Accelerated approval, later converted to traditional approval | Jan 6, 2023 |
| Aduhelm (aducanumab) | Biogen | BLA 761178 | Accelerated approval | Jun 7, 2021 |
Obesity and diabetes
| Drug | Sponsor | Application | FDA action | Date |
|---|---|---|---|---|
| Foundayo (orforglipron calcium) | Eli Lilly and Company | NDA 220934 | Approved | Apr 1, 2026 |
| Wegovy (semaglutide) | Novo Nordisk Inc. | NDA 218316 | Approved; one indication under accelerated approval | Dec 22, 2025 |
| Zepbound (tirzepatide) | Eli Lilly and Company | NDA 217806 | Approved | Nov 8, 2023 |
| Mounjaro (tirzepatide) | Eli Lilly and Company | NDA 215866 | Approved | May 13, 2022 |
| Wegovy (semaglutide) | Novo Nordisk Inc. | NDA 215256 | Approved | Jun 4, 2021 |
| Imcivree (setmelanotide acetate) | Rhythm Pharmaceuticals, Inc. | NDA 213793 | Approved | Nov 25, 2020 |
| Rybelsus (semaglutide) | Novo Nordisk Inc. | NDA 213182 | Approved | Jan 16, 2020 |
| Ozempic (semaglutide) | Novo Nordisk Inc. | NDA 213051 | Approved | Sep 20, 2019 |
| Ozempic (semaglutide) | Novo Nordisk, Inc. | NDA 209637 | Approved | Dec 5, 2017 |
| Bydureon Bcise (exenatide synthetic) | AstraZeneca AB | NDA 209210 | Approved | Oct 20, 2017 |
| Xultophy 100/3.6 (insulin degludec; liraglutide) | Novo Nordisk Inc. | BLA 208583 | Approved | Nov 21, 2016 |
| Soliqua 100/33 (insulin glargine; lixisenatide) | Sanofi-aventis U.S. LLC | BLA 208673 | Approved | Nov 21, 2016 |
| Adlyxin (lixisenatide) | Sanofi-aventis U.S. LLC | BLA 208471 | Approved | Jul 27, 2016 |
| Saxenda (liraglutide) | Novo Nordisk Inc. | NDA 206321 | Approved | Dec 23, 2014 |
| Trulicity (dulaglutide) | Eli Lilly and Company | BLA 125469 | Approved | Sep 18, 2014 |
| Contrave (bupropion hydrochloride; naltrexone hydrochloride) | Nalpropion Pharmaceuticals, LLC | NDA 200063 | Approved | Sep 10, 2014 |
| Qsymia (phentermine hydrochloride; topiramate) | Vivus | NDA 22580 | Approved | Jul 17, 2012 |
Updated Sep 30, 2026 · built from 20 FDA applications in the EphemerisX knowledge graph. This page is regenerated as FDA applications are added.