Lupin receives USFDA approval for antiretroviral drug

Lupin Limited has received final approval for its lamivudine tablets 150 mg and 300 mg from the US Food and Drugs Administration (USFDA) to market a generic version of ViiV Healthcare’s Epivir tablets 150 mg and 300 mg. Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary would commence marketing the product shortly.
 
Lupin’s lamivudine tablets 150 mg and 300 mg are the AB-rated generic equivalents of ViiV Healthcare’s Epivir tablets and are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.
 
Epivir tablets had annual US sales of $ 39.7 million, as per IMS MAT September, 2014.