FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT PEPCID RPD (FAMOTIDINE) ORALLY DISINTEGRATING TABLETS, 20 MILLIGRAMS AND 40 MILLIGRAMS WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Oct. 27 -- Food and Drug Administration has issued a notice called: Determination That PEPCID RPD (Famotidine) Orally Disintegrating Tablets, 20 Milligrams and 40 Milligrams Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Oct. 27 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, Agency, or we) has determined that PEPCID RPD (famotidine) orally disintegrating tablets, 20 milligrams (mg) and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for famotidine) o...