Aurobindo Pharma receives final approval for drug indicated for HIV treatment

23 May 2012 Evaluate

Aurobindo Pharma’s tentatively approved ANDA’s for Nevirapine Tablets 200 mg and Nevirapine Oral Suspension 50 mg/5 mL has received the final approval from the US Food & Drug Administration (USFDA). The products have a market size of approximately $125 million for the twelve months ending December 2011 according to the IMS and will be launched soon. Both the products have been approved out of Unit III formulations facility in Hyderabad, India.

Nevirapine Tablets 200 mg and Nevirapine Oral Suspension 50 mg/5 mL are the generic equivalent of Boehringer ingelheim Pharmaceutical Inc’s Viramune Tablets 200 mg and Oral Suspension 50 mg/ 5mL. The products are indicated as part of antiretroviral (ARV) combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected results.

Aurobindo now has a total of 151 ANDA approvals (125 final approvals including 1 from Aurolife Pharma LLC and 26 tentative approvals) from USFDA.

Aurobindo Pharma has a product presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc. The company is the market leader in semi-synthetic penicillin drugs.

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