FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT TOVALT ODT (ZOLPIDEM TARTRATE) ORALLY DISINTEGRATING TABLETS, 5 MILLIGRAMS AND 10 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, July 9 -- Food and Drug Administration has issued a notice called: Determination That TOVALT ODT (Zolpidem Tartrate) Orally Disintegrating Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on July 9 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has determined that TOVALT ODT (zolpidem tartrate) orally disintegrating tablets, 5 milligrams (mg) and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 zo...