Perrigo Files New Drug Application For Generic Version Of Onexton Gel

(RTTNews) - Perrigo Company plc (PRGO) announced it has filed an Abbreviated New Drug Application (ANDA) with the U.S. FDA for clindamycin, benzoyl peroxide topical gel, the generic version of Onexton gel.

Onexton gel is a prescription medicine indicated for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne. Perrigo said the company has notified Valeant Pharmaceuticals North America and Dow Pharmaceutical Sciences, Inc. (Valeant) the owner of both the New Drug Application and patents listed in FDA's Orange Book, of its filing. On February 3, 2017, Valeant filed suit in a U.S. District Court alleging patent infringement.