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Corporate - Regulatory Bodies & Rulings
Aurobindo gets USFDA nod for HIV drug

Our Bureau

Hyderabad, June 28

Aurobindo Pharma Ltd has announced that the United States Food and Drug Administration (USFDA) has granted tentative approval for Abacavir oral solution, an anti-retroviral component used in the paediatric AIDS population treatment. This is the first generic version approval given by USFDA.

Abacavir sulfate oral solution is the version of Ziagen solution, an anti-HIV medication manufactured by GlaxoSmithKline. The company said the product would now be available for consideration for purchase under the US President's emergency plan for AIDS relief. The company manufactures both active pharmaceutical ingredients and formulation for this generic. With this approval, the company's anti-retroviral portfolio with USFDA approval has increased to 14 products. Abacavir is one of the non-nucleoside reverse transcriptase inhibitors, a class of drugs that helps prevent AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

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