Actavis Files ANDA For Generic Version Of Acanya Gel - Quick Facts

(RTTNews) - Actavis plc (ACT) announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA seeking approval to market Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%, a generic version of Dow Pharmaceutical Sciences and Valeant Pharmaceuticals International's (VRX.TO, VRX) Acanya Gel, which is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Actavis believes it may be a "first applicant" to file an ANDA for the generic version of Acanya Gel.

Dow Pharmaceutical Sciences Inc. and Valeant Pharmaceuticals North America LLC filed suit against Actavis on October 24, 2013, in a U.S. District Court seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent No. 8,288,434. The lawsuit resulted 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, subject to any other exclusivities.