Regulatory timeline
Reported, not yet in the FDA record
Drugs@FDA publishes an action days to weeks after it is announced, so these are press reports, not primary records, and they are shown only while the database has nothing newer. Each is carried by at least two independent outlets. When the FDA publishes the action it appears in the table below and drops out of here.
- tirzepatide — US FDA approves Lilly's Mounjaro to reduce cardiovascular risk2026-08-31 · reported by BioSpace, Cardiovascular Business, Forbes, Healthline, Reuters, forbes.com, reuters.com · newest Drugs@FDA record for Mounjaro (NDA215866): 2026-08-27
Approved FDA submissions across all GLP-1 applications, newest first, from Drugs@FDA: original approvals, efficacy supplements and labeling changes. Labeling supplements are where new safety language and new indications actually land, and they are published months before most coverage notices them.
| Date | Drug | Action | Sponsor | Application |
|---|---|---|---|---|
| 2026-08-27 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2026-08-27 | tirzepatide | Efficacy MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2026-08-27 | tirzepatide | Efficacy MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2026-08-26 | tirzepatide | Efficacy ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-08-04 | orforglipron | Labeling FOUNDAYO | ELI LILLY AND CO | NDA220934 · label |
| 2026-07-01 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | SANDOZ | ANDA212972 |
| 2026-06-18 | semaglutide | Manufacturing (CMC) WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-06-18 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · label |
| 2026-06-15 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | MYLAN INSTITUTIONAL | ANDA213155 |
| 2026-06-02 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2026-06-01 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2026-05-05 | semaglutide | Manufacturing (CMC) WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-05-05 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · label |
| 2026-04-01 | orforglipron | Type 1 - New Molecular Entity original FOUNDAYO | ELI LILLY AND CO | NDA220934 · label |
| 2026-03-30 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | FRESENIUS KABI USA | ANDA212552 |
| 2026-03-19 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-03-19 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · label |
| 2026-03-12 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2026-03-12 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2026-03-12 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2026-03-11 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | BIOCON PHARMA | ANDA215245 |
| 2026-02-25 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-02-25 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · label |
| 2026-02-25 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-02-25 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2026-02-24 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | BIOCON PHARMA | ANDA217063 |
| 2026-02-24 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | ORBICULAR | ANDA217234 |
| 2026-01-30 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2026-01-29 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-01-29 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · label |
| 2026-01-20 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-01-20 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2026-01-14 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | ORBICULAR | ANDA217590 |
| 2026-01-07 | tirzepatide | Manufacturing (CMC) ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-01-07 | tirzepatide | Manufacturing (CMC) MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2025-12-22 | semaglutide | Type 3 - New Dosage Form original WEGOVY | NOVO | NDA218316 · label |
| 2025-12-19 | tirzepatide | Efficacy MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2025-11-21 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2025-10-17 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-17 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-17 | semaglutide | Efficacy OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-15 | liraglutide | Labeling LIRAGLUTIDE | NANJING KING FRIEND | ANDA218115 |
| 2025-10-14 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2025-10-14 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2025-10-14 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2025-10-14 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2025-10-14 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2025-10-14 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2025-09-25 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2025-09-25 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2025-09-02 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2025-08-27 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | TEVA PHARMS | ANDA214568 |
| 2025-08-15 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2025-07-22 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | LUPIN | ANDA215421 |
| 2025-05-28 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2025-05-28 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2025-05-28 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2025-05-28 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2025-05-28 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2025-05-28 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2025-05-28 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2025-05-28 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2025-05-28 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2025-05-28 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2025-04-02 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | NANJING KING FRIEND | ANDA218115 |
| 2025-02-12 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2025-02-07 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2025-01-28 | semaglutide | Efficacy OZEMPIC | NOVO | NDA209637 · label |
| 2024-12-23 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | HIKMA | ANDA215503 · label |
| 2024-12-20 | tirzepatide | Efficacy ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-12-09 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2024-12-09 | semaglutide | Efficacy OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2024-11-27 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2024-11-19 | exenatide | Generic approval (ANDA) original EXENATIDE SYNTHETIC | AMNEAL | ANDA206697 |
| 2024-11-01 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2024-11-01 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2024-11-01 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2024-11-01 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2024-11-01 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2024-11-01 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2024-11-01 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2024-11-01 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2024-11-01 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2024-11-01 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2024-11-01 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2024-11-01 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2024-11-01 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2024-11-01 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2024-11-01 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2024-11-01 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2024-10-18 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-10-18 | tirzepatide | Efficacy ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-10-18 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-10-18 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-10-18 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-03-28 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2024-03-08 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2024-03-06 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2024-01-24 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2023-11-08 | tirzepatide | Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated original ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2023-09-28 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2023-09-28 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2023-09-22 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2023-09-22 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2023-07-28 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2023-07-28 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2023-07-21 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2023-07-10 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2023-07-05 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2023-04-20 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2023-02-14 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2023-01-12 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2022-12-23 | semaglutide | Efficacy WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2022-12-21 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2022-12-21 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2022-12-21 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2022-11-17 | dulaglutide | Efficacy TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2022-10-06 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2022-08-24 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2022-07-26 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
European authorisations
The same molecules as authorised by the European Medicines Agency, from the public register of medicines. A drug approved in one jurisdiction is often not approved in the other, and the indication wording frequently differs — both are worth checking before assuming a US approval carries over.
| First authorised | Medicine | Molecule | Status | Therapeutic area | Record |
|---|---|---|---|---|---|
| 2022-07-18 | Mounjaro | tirzepatide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2021-11-11 | Wegovy | semaglutide | Authorised | Obesity, Overweight | EPAR |
| 2020-05-27 | Rybelsus | semaglutide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2018-07-02 | Trulicity | dulaglutide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2018-06-28 | Saxenda | liraglutide | Authorised | Obesity, Overweight | EPAR |
| 2018-06-26 | Byetta | exenatide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2018-06-07 | Xultophy | liraglutide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2018-05-31 | Ozempic | semaglutide | Authorised | Diabetes Mellitus | EPAR |
| 2017-11-10 | Bydureon | exenatide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2017-09-22 | Victoza | liraglutide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2017-09-18 | Lyxumia | lixisenatide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2017-09-14 | Suliqua | lixisenatide | Authorised | Diabetes Mellitus, Type 2 | EPAR |
| 2017-09-14 | Eperzan | albiglutide | Withdrawn | Diabetes Mellitus, Type 2 | EPAR |