Lupin receives FDA Approval for Generic Epivir Tablets

26 Dec 2014 Evaluate

Lupin has received final approval for its Lamivudine Tablets 150 mg and 300 mg from the United States Food and Drugs Administration (FDA) 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. 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 (IMS MAT September, 2014).

Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations as well as biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.

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