Mylan Inc's subsidiary Mylan Pharmaceuticals Inc. has received final approval from the US 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.
Mylan CEO Heather Bresch said: "The launch of Nevirapine tablets, 200 mg, in the US 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 US."
Nevirapine tablets, 200 mg, had US 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 December 31, 2011, according to IMS Health.