Lupin, Aurobindo get USFDA nod for HIV drug
New Delhi: Drug firms Lupin Ltd and Aurobindo Pharma today said they have received US health regulator`s approval to sell generic Combivir tablets, used in treating HIV infection, in the American market.
Lupin Pharmaceuticals Inc, a subsidiary of Lupin Ltd, has received final approval from US Food and Drug Administration (USFDA) for its generic Lamivudine and
Zidovudine combination tablet in strength of 150mg/300 mg, Lupin said in a statement.
Similarly, Hyderabad-headquartered Aurobindo Pharma also said it has received approval from the USFDA for generic Lamivudine and Zidovudine tablets of the same strength.
Both the companies` products are the generic equivalent of Viiv Healthcare`s Combivir tablets.
Lupin said it has already started shipping the product to the US market.
According to IMS Health sales data for the twelve months ended December 2011, US sales of Combivir tablets stood at around USD 275 million.
Lamivudine-Zidovudine combination is indicated along with other antiretroviral agents for the treatment of HIV-1 infection.
Shares of Lupin were trading at Rs 544.75 on the BSE in afternoon trade, up 1.33 per cent from its previous close. Scrips of Aurobindo were down 2.59 per cent at Rs 103.50 on the BSE.
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