Alkermes Announces Notification of Tentative FDA Advisory Committee Meeting to Review VIVITROL(R) for Opioid Dependence

Alkermes, Inc. (NASDAQ: ALKS) announced that the U.S. Food and Drug Administration (FDA) has notified the company of the tentative scheduling of a Psychopharmacologic Drugs Advisory Committee meeting on September 16, 2010, for the review of the company's supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence. Notification of this potential advisory committee meeting follows a designation in May 2010 by the FDA of priority review of the VIVITROL sNDA, a designation that accelerates the FDA's target review timeline from ten to six months for drugs that offer major advances in treatment or provide a treatment...

Want to see the full article?

• Purchase this article for only $3.00