(By Balaseshan) Mylan Inc. (NASDAQ:MYL) said its subsidiary launched the generic version of Viramune tablets to treat patients living with HIV/AIDS, after it got the final FDA approval. This expands further the reach of Mylan's global antiretroviral portfolio.
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.
The Nevirapine product is the generic version of Boehringer Ingelheim's Viramune and is indicated for combination antiretroviral treatment of HIV-1 infection.
Nevirapine Tablets, 200 mg, had U.S. sales of about $116.6 million for the 12 months ending March 31, 2012, according to IMS Health. Mylan is shipping its product immediately.
Mylan's Chief Executive Heather Bresch said about one-third of HIV/AIDS patients in developing countries depend on a Mylan antiretroviral product, and the company is committed to continue bringing affordable, high quality generic antiretrovirals to market in the U.S.
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 December 31, 2011, according to IMS Health.
MYL is trading down 3.24% at $20.58 on Wednesday. The stock has been trading between $15.49 and $25 for the past 52 weeks.