Perrigo Company received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application for over-the-counter (OTC) Minoxidil 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 in the United States on March 1, 2012 or earlier, under certain circumstances. The product will be entitled to 180 days of generic exclusivity upon launch.
Release Date: May 2, 2011
Source: Perrigo Company
