Perrigo Announces FDA Final Approval for Minoxidil Foam - Generic Equivalent to Men's Rogaine[R] Foam.

Perrigo Company (Nasdaq: PRGO; TASE) 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[R] Foam (see also U.S. Food and Drug Administration).

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[R] 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[R] (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."

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) 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. Visit Perrigo on the Internet (http://www.perrigo.com).

Keywords: FDA, Generics, Legal Issues, Perrigo, Perrigo Company, Pharmaceutical Company, Regulatory Actions, U.S. Food and Drug Administration.

This article was prepared by Biotech Week editors from staff and other reports. Copyright 2011, Biotech Week via NewsRx.com.