FDA approvals
2022 GLP-1 FDA approvals & regulatory actions
5 regulatory events affecting GLP-1 medications in 2022.
- New indication
Wegovy
FDA expanded Wegovy approval to pediatric patients aged 12 years and older with obesity (STEP TEENS trial).
Read on fda.gov → - Shortage status
Mounjaro
FDA added Mounjaro to the Drug Shortage List due to demand exceeding supply.
Read on fda.gov → - Shortage status
Ozempic
FDA added Ozempic 0.25, 0.5, 1, and 2 mg presentations to the Drug Shortage List due to increased demand for off-label weight-loss use.
Read on fda.gov → - Original approval
Mounjaro
First dual GIP/GLP-1 receptor agonist approved — once-weekly tirzepatide for type 2 diabetes. SURPASS trial program showed superior A1C reduction vs semaglutide.
Read on fda.gov → - Shortage status
Wegovy
FDA added Wegovy to the Drug Shortage List due to manufacturing constraints — shortage persisted intermittently via 2024.
Read on fda.gov →