All regulations
Nonrulemaking
FDA
FDA-2025-P-3849
Requests that the FDA determine whether OZEMPIC (semaglutide) Injection, 2 mg/1.5 mL (1.34 mg/mL) was withdrawn for safety or effectiveness reasons.
Documents
5
Comments
0
Description
CLOSED
Key Dates
Comment Period OpensSep 15, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CDER
Citizen Petition
Hyman Phelps and McNamara PC
determine whether OZEMPIC semaglutide Injection
2 mg 1 5 mL 1 34 mg mL
approved under
New Drug Application number 209637
held by Novo Nordisk Inc
Data from Regulations.gov