FDA Issues Approvable Letter For Alkermes (ALKS)' VIVITROL(TM) (Formerly VIVITREX(R)), For The Treatment Of Alcohol Dependence
12/28/2005 6:36:44 PM
CAMBRIDGE, Mass.& FRAZER, Pa.--(BUSINESS WIRE)--Dec. 28, 2005--Alkermes, Inc. (Nasdaq: ALKS) and Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) issued an approvable letter for VIVITROL(TM) (naltrexone for extended-release injectable suspension), which is under review for the treatment of alcohol dependence in combination with a treatment program that includes psychosocial support. The New Drug Application (NDA) for VIVITROL, formerly known as VIVITREX(R), was submitted on March 31, 2005. Alkermes and Cephalon continue to prepare for the launch of VIVITROL during the second quarter of 2006.