Aurobindo Pharma gets USFDA nod for anti-HIV drug

22 December 2008

Mumbai: Aurobindo Pharma has received tentative approval from the US Food and Drugs Administration (USFDA) to manufacture and market its fixed dose combination Abacavir Sulfate / Lamivudine tablets 60/30mg.

The new drug application (NDA) 22-295 provides for the use of abacavir sulfate/lamivudine tablets 60/30mg for the treatment of HIV infections, Aurobindo Pharma said in a filing with the Bombay Stock Exchange.

Abacavir sulfate tablets are used with other antiretroviral drugs in the treatment of HIV infection in adults and children above 3 months of age.

Lamivudine is used for the treatment of chronic hepatitis B at a lower dose than for treatment of HIV.

The new drug application (NDA) 22-295 provides for the use of abacavir sulfate/ lamivudine tablets 60/30 mg for the treatment of HIV infections.

The company had earlier received tentative approvals to co-packaged lamivudine/zidovudine tablets + abacavir sulfate tablets 150/300mg + 300mg and abacavir sulfate / lamivudine tablets 600/300 mg