Mylan Pharmaceuticals has gained final FDA approval for its abbreviated new drug application (ANDA) for Nevirapine Tablets USP, 200mg and initiated the shipment of the product.
The generic version of Boehringer Ingelheim's Viramune is indicated for combination antiretroviral (ARV) treatment of HIV-1 infection.
Mylan CEO Heather Bresch said the launch of Nevirapine Tablets, 200mg, in the US 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," Bresch added.
According to IMS Health, for the 12 months ending 31 March 2012, Nevirapine Tablets, 200mg, had US sales of approximately $116.6m.
