All regulations
Nonrulemaking
FDA
FDA-2025-P-6392
Requests that the FDA to determine whether Methergine (methylergonovine maleate) Injection, 0.2 mg/mL (NDA # 0069035) held by Edison Therapeutics LLC has been voluntarily withdrawn or withheld from sale for reasons of safety or efficacy.
Documents
5
Comments
0
Description
CLOSED
Key Dates
Comment Period OpensNov 21, 2025
Documents
Keywords
CDER
Citizen Petition
Gland Pharma Limited
determine whether Methergine
methylergonovine maleate Injection 0 2 mg mL
NDA 0069035 held by Edison Therapeutics LLC
has been voluntarily withdrawn or withheld
from sale for reasons of safety or efficacy
Data from Regulations.gov