Moneycontrol
May 23, 2012 11:04 PM IST | Source: Moneycontrol.com

Aurobindo Pharma gets US FDA nod for generic HIV drug

Aurobindo Pharma on Wednesday said its tentatively approved abbreviated new drug applications for Nevirapine Tablets 200mg and Nevirapine oral suspension have received final approval from US Food and Drug Administration (FDA).

 
 
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Aurobindo Pharma on Wednesday said its tentatively approved abbreviated new drug applications for Nevirapine Tablets 200mg and Nevirapine oral suspension have received final approval from US Food and Drug Administration (FDA).


Aurobindo's Nevirapine tablets and oral suspension are generic equivalent of Boehringer Ingelheim Pharmaceutical Inc's Viramune tablets and oral suspension. The drug is used as a part of antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults.


The two products had a market size of about USD 125 million for year ended Dec 2011, the company said, citing IMS Health data.


Aurobindo said both its products have been approved out of Unit III formulations facility in Hyderabad and will launched soon.


It now has 125 final ANDA approvals and 26 tentative approvals  from US FDA.

Aurobindo Pharma shares were up 1.4% at Rs 111.70 on NSE in afternoon trade.

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