Categories: Approval

Lupin gets USFDA approval for HIV drug

New Delhi, Dec 30, 2014 – Drug major Lupin has received US health regulator’s approval to market a generic version of ViiV Healthcare’s Epivir Tablets, used in treating HIV infection, in the American market.

The Mumbai-based firm has received final approval from the US Food and Drug Administration ( USFDA) for itsLamivudine tablets in strengths of 150 mg and 300 mg, Lupin Ltd said in a statement.

Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary, would commence marketing the product shortly, it added.

Epivir tablets are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection.

According to IMS MAT September 2014 sales data, Epivir tablets had annual US sales of USD 39.7 million.

Lupin shares were trading at Rs 1,401 apiece on the BSE, down 0.12 per cent from their previous close. PTI

The Pharma Times News Bureau

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