FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ROXICET (OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, 5 MILLIGRAMS AND 325 MILLIGRAMS, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Aug. 4 -- Food and Drug Administration has issued a notice called: Determination That ROXICET (Oxycodone Hydrochloride and Acetaminophen) Tablet, 5 Milligrams and 325 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on Aug. 4 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that ROXICET (oxycodone hydrochloride (HCl) and acetaminophen) tablet, 5 milligrams (mg)/325 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for oxycodone...