Lupin’s arm receives tentative approval from USFDA for generic Lexiva Tablets

27 Jul 2016 Evaluate

Lupin’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 (ViiV) Lexiva Tablets, 700 mg (Fosamprenavir Calcium Tablets, 700 mg). This product was filed from Lupin’s Goa formulations manufacturing facility.

Lupin’s Fosamprenavir Calcium Tablets, 700 mg are the AB rated generic equivalent of ViiV Healthcare’s Lexiva Tablets. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Lexiva Tablets had US sales of $71.6 million, as per IMS MAT March 2016 data.

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded & generic formulations, biotechnology products and APIs globally.


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