Perrigo Confirms Filing ANDA with FDA For Generic Acanya

Perrigo Company

announced that it has filed with the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% and has notified Dow Pharmasciences, the owner of the New Drug Application (NDA) of its filing. On November 15, 2013, Dow Pharmasciences and Valeant Pharmaceuticals filed suit against Perrigo in the United States District Court for the District of New Jersey, alleging patent infringement. This action formally initiates the process under the Hatch-Waxman Act.  Acanya® Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older. Annual sales were approximately $122 million annually, as measured by Symphony Health Solutions. Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing is another example of our investment in extended topical product development. As always, Perrigo is committed to making quality healthcare more affordable for our customers."                   From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional