Lupin receives tentative approval for generic Lexiva tablets from US FDA

It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection

Lupin has received tentative approval from the United States Food and Drug Administration (FDA) 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 (IMS MAT March 2016).