DUPONT MERCK REVIA APPROVAL FOR ALCOHOLISM ADJUNCTIVE THERAPY INCLUDES PHASE IV COMMITMENTS BASED ON PRODUCT SALES; SNDA APPROVED ON DEC. 30
Executive Summary
DuPont Merck will tailor the type of Phase IV studies that it will conduct on ReVia (naltrexone) for the treatment of alcoholism based on the extent of use of the product, according to an agreement with FDA preceding the drug's recent approval for the new indication. A supplemental NDA (18-932/S-010) was approved on Dec. 30.