FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT METHERGINE (METHYLERGONOVINE MALEATE) INJECTION, 0.2 MILLIGRAM/MILLILITER, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, March 18 -- Food and Drug Administration has issued a notice called: Determination That METHERGINE (Methylergonovine Maleate) Injection, 0.2 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on March 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that METHERGINE (methylergonovine maleate) injection, 0.2 milligram (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for methylergonovine maleate injec...