FDA approvals
2025 GLP-1 FDA approvals & regulatory actions
3 regulatory events affecting GLP-1 medications in 2025.
- Safety update
Compounded tirzepatide
FDA reaffirmed enforcement against unauthorized compounded tirzepatide after court ruling — outsourcing facilities ordered to halt production.
Read on fda.gov → - Shortage status
Wegovy
FDA declared the semaglutide shortage resolved — Wegovy and Ozempic removed from the active shortage list (the tirzepatide shortage had resolved earlier, Oct 2, 2024). Compounder wind-down timelines followed.
Read on fda.gov → - New indication
Ozempic
FDA approved Ozempic for reducing risk of worsening kidney disease, kidney failure, and CV death in adults with T2D and chronic kidney disease (FLOW trial).
Read on fda.gov →