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Actavis Inc Files Abbreviated New Drug Application With U.S. FDA Seeking Approval To Market Testosterone Gel, 1.62%


Monday, 1 Apr 2013 08:00am EDT 

Actavis Inc announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Testosterone Gel, 1.62%. Actavis' ANDA product is a generic version of AbbVie Inc.'s AndroGel 1.62%, which is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Unimed Pharmaceuticals, LLC, which is a wholly owned subsidiary of AbbVie Inc., and Besins Healthcare Inc. filed suit against Actavis on March 29, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing ANDA product prior to the expiration of U.S. Patent No. 6,503,894. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner. 

Company Quote

237.21
5.8 +2.51%
23 Oct 2014