Vivitrol gains FDA approvable letter

USA-based pharmaceutical firms Alkermes and Cephalon say that the Food and Drug Administration has issued an approvable letter for Vivitrol (naltrexone for extended-release injectable suspension), its alcohol dependence medication. The companies submitted the New Drug Application for Vivitrol, formerly known as Vivitrex, last spring (Marketletter April 11, 2005).

The approval is dependent on finalization of product labeling and the provision of preclinical pharmacokinetic data in support of existing oral naltrexone information.

"Our plans for the launch of Vivitrol in the second quarter of 2006 are on track," said Frank Baldino, chairman of Cephalon, adding that both firms intended to design education and training programs to ensure that physicians and counsellors can identify patients who would benefit from treatment.