Perrigo Files For Generic Version Of Gynazole-1 Cream

Allegan-based Perrigo Co. (Nasdaq: PRGO) Friday announced that it has filed with the United States Food and Drug Administration an Abbreviated New Drug Application for butoconazole nitrate vaginal cream, 2 percent. Perrigo also said it has notified KV Pharmaceutical Co., the owner of the New Drug Application as well as FemmePharma, the listed owner of the patent, of its ANDA filing. KV is a licensee under the patent. Perrigo believes it is first-to-file on this product.

On July 29, KV Pharmaceutical filed suit in the United States District Court for the District of Delaware, alleging patent infringement to prevent Perrigo from proceeding with the commercialization of this product. This action formally initiates the process under the Hatch-Waxman Act. The suit also named FemmePharma as a defendant as it had not agreed to join KV as a plaintiff in the suit.

Gynazole·1 (butoconazole nitrate) vaginal cream is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). Prior to its being discontinued in January 2009 due to manufacturing issues at KV, its annual sales were approximately $28 million annually, as measured by Wolters Kluwer Health.

Said Perrigo chairman and CEO Joseph C. Papa: "This filing is another example of our investment in new products and expansion of our product portfolio. The first to file status also reflects Perrigo's continued focus on being first to market with new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers."

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

More at www.perrigo.com.

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