Actavis seeks approval for generic AndroGel product

Jessica Perry//April 1, 2013

Generic drug developer Actavis Inc., of Parsippany, today announced it has filed an abbreviated new drug application with the U.S. Food and Drug Administration seeking approval to market a generic version of AbbVie Inc.’s AndroGel.According to an announcement from the company, the drug is intended as replacement therapy in men for conditions associated with a deficiency or absence of endogenous testosterone.

Unimed Pharmaceuticals LLC, a wholly owned subsidiary of AbbVie Inc., and Besins Healthcare Inc. filed suit against Actavis on March 29 to prevent Actavis from commercializing the product prior to its patent expiration, according to Actavis’ statement.