FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT KLONOPIN (CLONAZEPAM) TABLETS, 0.125 MILLIGRAMS AND 0.25 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Feb. 23 -- Food and Drug Administration has issued a notice called: Determination That Klonopin (Clonazepam) Tablets, 0.125 Milligrams and 0.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Feb. 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0.125 milligrams (mg) and 0.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 clonazepam tablets, 0.125 mg and 0.25 mg, if all other ...