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

Perrigo Company PRGO 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 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.