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Perrigo Announces FDA Approval For New Generic

Allegan-based Perrigo Co. Wednesday announced it received FDA approval from the United States Food and Drug Administration to manufacture and market Imiquimod Cream, 5 percent. Perrigo will vertically integrate this product with their own API.

The product is the generic equivalent of Graceway Pharmaceuticals Aldara Cream, 5 percent, a topical treatment for actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts in patients 12 years old or older.

Aldara had sales of approximately $382 million prior to generic market formation, as measured by Wolters Kluwer Health.

Said Perrigo chairman and CEO Joseph C. Papa stated: "This approval is another example of Perrigo's commitment to expand our portfolio of generic extended topical prescription products and to bring new products to market. Perrigo is working every day to make quality health care more affordable."

Perrigo (Nasdaq: PRGO) develops, manufactures and distributes over-the-counter and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients 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.

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