PITTSBURGH, May 23, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nevirapine Tablets USP, 200 mg. This product is the generic version of Boehringer Ingelheim's Viramune® and is indicated for combination antiretroviral (ARV) treatment of HIV-1 infection. (1)
Mylan CEO Heather Bresch said: "The launch of Nevirapine Tablets, 200 mg, in the U.S. further expands the reach of Mylan's global ARV portfolio. Currently, approximately one-third of HIV/AIDS patients in developing countries depend on a Mylan ARV product, and the company is committed to continue bringing affordable, high quality generic ARVs to market in the U.S."
Nevirapine Tablets, 200 mg, had U.S. sales of approximately $116.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping its product immediately.
Currently, Mylan has 173 ANDAs pending FDA approval representing $92 billion in annual sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $25.5 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com
(1) Both fatal and non-fatal liver damage and skin reactions have been reported in patients taking Nevirapine. Patients must be closely monitored during the first 18 weeks of therapy to detect these conditions.
SOURCE Mylan Inc.