Perrigo Company Confirms FDA Tentative Approval For New Drug

ALLEGAN -- Perrigo Co. (Nasdaq: PRGO) said Thursday it had received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Clobetasol Propionate Emulsion Foam, 0.05 percent. Perrigo believes it is first-to-file on this product.

On July 12, Stiefel Research Australia Pty. Ltd. filed a patent infringement suit in the United States District Court for the District of Delaware to prevent Perrigo from commercializing this product.  This action, which is still pending, formally initiated the process under the Hatch-Waxman Act.

The product is the AB-rated equivalent to Stiefel Laboratories' Olux -E Foam, 0.05 percent, a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand were approximately $40 million, according to Wolters Kluwer data for the twelve months ending September 2011.

"This tentative approval reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders, it is also another example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business," Perrigo chairman and CEO Joseph C. Papa said.

Perrigo develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients. Perrigo is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia.

More at www.perrigo.com.