ALLEGAN (WWJ) — The Allegan generic drugmaker and store brand health products producer Perrigo Co. (NYSE: PRGO) Wednesday announced that it has filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application for Clindamycin Phosphate and Benzoyl Peroxide Gel 1.2%/2.5% and has notified Dow Pharmasciences, the owner of the New Drug Application, of its filing.
On Nov. 15, 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 in patients 12 years or older. Annual sales were approximately $122 million annually, as measured by Symphony Health Solutions.
“This filing is another example of our investment in extended topical product development,” said errigo chairman and CEO Joseph C. Papa. “As always, Perrigo is committed to making quality healthcare more affordable for our customers.”
Established as a packager of generic home remedies in 1887, Allegan-based Perrigo is now the world’s largest manufacturer of over-the-counter pharmaceutical products for the store brand market. It also develops and makes generic prescription pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients. It operates in the United States, Israel, Mexico, the United Kingdom, India, China and Australia.
More at http://www.perrigo.com.