Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Minoxidil Foam, a generic version of Men's Rogaine® Foam.
Perrigo had been sued for patent infringement by Stiefel Research Australia Pty. Ltd., a GSK Company, when it submitted its Paragraph IV ANDA. Under the terms of the settlement reached between the parties in February 2011, Perrigo can launch the generic version of Men's Rogaine® Foam in the U.S. on March 1, 2012, or earlier, under certain circumstances. The product will be entitled to 180 days of generic exclusivity upon launch.
Rogaine® (Minoxidil) Foam is used to regrow hair on the top of the scalp, and has annual sales of approximately $60 million, as measured by Information Resources, Inc.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This is another example of Perrigo's commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers."
Study finds social and psychological factors fuel teen cravings for ultra-processed foods during screen time