Lupin’s arm gets USFDA approval for generic Combivir tablets

Pharma Major, Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Lamivudine and Zidovudine tablets, 150 mg/300 mg from the United States Food and Drugs Administration (USFDA) for the company's abbreviated new drug application (ANDA) to market a generic version of Combivir tablets, 150 mg/300 tug of ViiV Healthcare.

Lupin's Lamivudine and Zidovudine tablets are the AB-rated generic equivalent of ViiV Healthcare's Combivir tablets, 150 mg/300 mg. Lamivudine - Zidovudine is a combination of two nucleoside analogue reverse transcriptase inhibitors and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

According to IMS Health sales data, Combivir tablets, 150 mg/300 mg had annual US sales of approximately $295 million for the twelve months ending June 2011.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. Lupin has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.