FDA approvals
2023 GLP-1 FDA approvals & regulatory actions
4 regulatory events affecting GLP-1 medications in 2023.
- Original approval
Zepbound
Tirzepatide approved for chronic weight management at doses to 15 mg/week. SURMOUNT-1 trial showed ~22% body-weight reduction at 72 weeks.
Read on fda.gov → - Safety update
Ozempic
FDA updated Ozempic, Wegovy, and Saxenda labels to include ileus (intestinal blockage) as adverse reaction following postmarket reports.
Read on fda.gov → - Safety update
Compounded semaglutide
FDA issued public alert about adverse events from compounded semaglutide — flagged use of semaglutide salt forms (sodium, acetate) not present in FDA-approved products.
Read on fda.gov → - Discontinuation
Adlyxin
Sanofi discontinued Adlyxin in the US market for commercial reasons.
Read on fda.gov →