FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT REVIA (NALTREXONE HYDROCHLORIDE) TABLETS, 50 MILLIGRAMS WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness.

The notice was published in the Federal Register on April 16 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) has determined that REVIA (naltrexone hydrochloride) tablets, 50 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and ...