Aurobindo Pharma has received final approval from the US health regulator for its generic Nevirapine tablets and oral suspension used for treating human immunodeficiency virus (HIV).
The company has received final approval from the United States Food and Drug Administration (USFDA) for its Nevirapine tablets in the strength of 200 mg and Nevirapine oral suspension in the strength of 50 mg/5ml, Aurobindo Pharma said in a statement today.
The company plans to soon launch the products manufactured at its Hyderabad facility in the US market, it added.
According to IMS health data, the products have a market size of about $125 million for the 12 months ended December 2011, Aurobindo Pharma said.
Nevirapine tablets and oral suspension are generic equivalent of Boehringer Ingelheim Pharmaceutical Inc’s Viramune tablets and oral suspension in the same strengths.
“The products are indicated as part of antiretroviral combination therapy for the treatment of HIV infected adults,” it added.
The company said it currently has 151 abbreviated new drug application (ANDA) approvals from the USFDA.
Shares of Aurobindo Pharma were trading at Rs 111.50 in the afternoon trade on the BSE today, up 1.23 per cent from their previous close.