Lupin receives US FDA approval for Epivir tabs

Would commence marketing the product shortly

Lupin has received final approval for its Lamivudine tablets 150 mg and 300 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of ViiV Healthcare’s Epivir tablets 150 mg and 300 mg. Lupin Pharmaceuticals, 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. Limitation of use: The dosage of this product is for HIV-1 and not for HBV.

Epivir tablets had annual US sales of $ 39.7 million.