Manufacturer of generic pharmaceuticals and active pharmaceutical ingredients Aurobindo Pharma Ltd. said it had received final approval for its tentatively approved ANDAs for Nevirapine tablets 200mg covered under ANDA 077521 and Nevirapine Oral Suspension 50mg/5mL falling under ANDA 077702 from the US FDA.
Nevirapine tablets 200 mg and Oral Suspension 50mg/5mL are the generic equivalent of Boehringer Ingelheim Pharmaceutical Inc.'s Viramune tablets 200 mg and Oral Suspension 50mg/5mL.
The products are indicated as part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults.
The company said both the products were approved out of Unit III formulation facility in Hyderabad, India. It said the products would be launched soon.
As per IMS Health data, the products had a market size of around $125 million for the twelve months ended December 2011.
The company now has a total of 151 ANDA approvals (125 final approvals including one from Aurolife Pharma LLC and 26 tentative approvals) from US FDA.
At the BSE, Aurobindo Pharma shares are currently trading at Rs,111.60, up 1.32 percent from the previous close.
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