Aurobindo receives FDA approval for Nevirapine

Bangalore: India-based Aurobindo Pharma has received final approval from the US Food & Drug Administration for Nevirapine tablets 200mg and Nevirapine oral suspension 50mg/5mL.

The products held a market size of approximately $125 million for the twelve months ending December 2011, according to IMS.

Nevirapine tablets 200mg and oral suspension 50mg/5mL are the generic equivalents of Boehringer Ingelheim's Viramune tablets 200mg and oral suspension 50mg/5mL. The products are indicated as part of antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults.

Both the products have been approved out of Unit III formulations facility in Hyderabad, India.

Aurobindo now has a total of 151 ANDA approvals (125 final approvals, including one from Aurolife Pharma and 26 tentative approvals) from the USFDA.