Perrigo receives FDA approval to manufacture, market Imiquimod Cream, 5%

Perrigo Company (Nasdaq: PRGO;TASE) announced it received FDA approval from the U.S. Food and Drug Administration to manufacture and market Imiquimod Cream, 5%. Perrigo will vertically integrate this product with their own API.

The product is the generic equivalent of Graceway Pharmaceuticals Aldara® Cream, 5%, 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.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is another example of Perrigo's commitment to expand our portfolio of generic extended topical Rx products and to bring new products to market. Perrigo is working every day to make quality healthcare more affordable."