Regulatory timeline
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.
299
approved submissions
31
original approvals
31
applications
17
sponsors
| Date | Drug | Action | Sponsor | Application |
|---|---|---|---|---|
| 2026-10-02 | exenatide | Labeling EXENATIDE SYNTHETIC | AMNEAL | ANDA206697 |
| 2026-10-02 | exenatide | Labeling EXENATIDE SYNTHETIC | AMNEAL | ANDA206697 |
| 2026-10-02 | exenatide | Labeling EXENATIDE SYNTHETIC | AMNEAL | ANDA206697 |
| 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) 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 ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2026-03-12 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2026-03-11 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | BIOCON PHARMA | ANDA215245 |
| 2026-02-25 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2026-02-25 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2026-02-25 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-02-25 | semaglutide | Labeling WEGOVY | NOVO | NDA218316 · 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 MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2026-01-20 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · label |
| 2026-01-14 | liraglutide | Generic approval (ANDA) original LIRAGLUTIDE | ORBICULAR | ANDA217590 |
| 2026-01-07 | tirzepatide | Manufacturing (CMC) MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2026-01-07 | tirzepatide | Manufacturing (CMC) ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · 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 | Efficacy OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-17 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-17 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2025-10-15 | liraglutide | Labeling LIRAGLUTIDE | NANJING KING FRIEND | ANDA218115 |
| 2025-10-14 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2025-10-14 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2025-10-14 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2025-10-14 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2025-10-14 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2025-10-14 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · label |
| 2025-09-25 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · label |
| 2025-09-25 | tirzepatide | Labeling ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN | ELI LILLY AND CO | NDA217806 · 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 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2025-05-28 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2025-05-28 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2025-05-28 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2025-05-28 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2025-05-28 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2025-05-28 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2025-05-28 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2025-05-28 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2025-05-28 | tirzepatide | Labeling MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN | ELI LILLY AND CO | NDA215866 · 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 | Efficacy OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2024-12-09 | semaglutide | Labeling 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 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2024-11-01 | dulaglutide | Labeling TRULICITY | ELI LILLY AND CO | BLA125469 · label |
| 2024-11-01 | lixisenatide | Labeling ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2024-11-01 | liraglutide | Labeling XULTOPHY 100/3.6 | NOVO | BLA208583 · label |
| 2024-11-01 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · label |
| 2024-11-01 | exenatide | Labeling BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2024-11-01 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2024-11-01 | liraglutide | Labeling VICTOZA | NOVO NORDISK INC | NDA022341 · label |
| 2024-11-01 | liraglutide | Labeling SAXENDA | NOVO | NDA206321 · label |
| 2024-11-01 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · label |
| 2024-11-01 | semaglutide | Labeling OZEMPIC | NOVO | NDA209637 · label |
| 2024-11-01 | semaglutide | Labeling OZEMPIC, RYBELSUS | NOVO | NDA213051 · label |
| 2024-11-01 | semaglutide | Labeling WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD | NOVO | NDA215256 · 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 |
| 2024-10-18 | 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 |
| 2024-10-18 | 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 ADLYXIN | SANOFI-AVENTIS US | BLA208471 · label |
| 2023-09-28 | lixisenatide | Labeling SOLIQUA 100/33 | SANOFI-AVENTIS US | BLA208673 · 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 BYETTA | ASTRAZENECA AB | NDA021773 · label |
| 2022-12-21 | exenatide | Labeling BYDUREON, BYDUREON PEN | ASTRAZENECA AB | NDA022200 · label |
| 2022-12-21 | exenatide | Labeling BYDUREON BCISE | ASTRAZENECA AB | NDA209210 · 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 |