ALLEGAN, Mich., Aug. 19 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO;TASE) announced its filing with the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clobetasol propionate shampoo, 0.05%, and notified Galderma, the listed patent owner.
On August 17, 2010, Galderma filed suit alleging patent infringement in the United States District Court for the Northern District of Texas to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act.
The product is substitutable to Galderma's Clobex® Shampoo, 0.05%, a topical corticosteroid indicated for the treatment of moderate to severe psoriasis of the scalp. Sales for the brand were approximately $53 million, according to Wolters Kluwer data for the twelve months ending June 2010.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This filing reflects our razor focused strategy of bringing new extended topical products to market and making quality healthcare more affordable for our customers."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. The Company is the world's largest store brand manufacturer of OTC pharmaceutical products and infant formulas. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor creat