NEW DELHI, May 23: Aurobindo Pharma today said it 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.
The company plans to launch the products manufactured at its Hyderabad facility soon in the US market, it added.
According to IMS health data the products have a market size of approximately USD 125 million for the twelve months ending 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.
(PTI)
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