Lupin gets USFDA tentative nod for generic Lexiva tablets
Drug firm Lupin has received tentative approval from the US health regulator to market generic Lexiva tablets used for treatment of HIV infection in the American market.
The company's "US subsidiary Lupin Pharmaceuticals Inc has received tentative approval from the United States Food and Drug Administration (USFDA) to market a generic equivalent of ViiV Healthcare's Lexiva tablets, 700 mg (fosamprenavir calcium tablets, 700 mg)," Lupin said in a filing to BSE.
This product was filed from the firm's Goa formulations manufacturing facility, it added.
Quoting IMS MAT March 2016 data, Lupin said, Lexiva tablets had US sales of USD 71.6 million.
The product is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, it added.
Shares of Lupin were trading at Rs 1,718.90 per scrip in the late afternoon trade on BSE, up 1.12 per cent from its previous close.