9/16/10 - Shares of Alkermes, Inc. (ALKS) have been halted this morning as the FDA advisory panel takes a vote on Vivitrol For Opioid Dependence. Alkermes, Inc. closed at $14.22 before the trading halt this morning.
The sNDA for VIVITROL for the treatment of opioid dependence was submitted in April 2010. In May the FDA designated the sNDA a priority review, 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 where no adequate therapy exists. With priority review, the Prescription Drug User Fee Act (PDUFA) date for the FDA’s decision regarding approval of the VIVITROL sNDA for opioid dependence is October 12, 2010.
Also halted - ARNA
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