Mylan Launches Generic Version of Viramune Tablets

Mylan Inc.

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.