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Aurobindo gets US FDA nod for Tenofovir Disoproxil Fumarate pills

Our Bureau, MumbaiFriday, February 20, 2009, 08:00 Hrs  [IST]

Aurobindo Pharma has received tentative approval for Tenofovir Disoproxil Fumarate tablets, 300 mg from the US Food and Drug Administration (USFDA). Tenofovir Disoproxil Fumarate tablets, 300 mg is the generic equivalent of Gilead Sciences Inc's Viread tablets 300 mg and falls under the Anti-Retroval (ARV) segment. It is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. This ANDA was reviewed under the expedited provisions of the President's Emergency Plan for AIDS relief (PEPFAR). Aurobindo has obtained a license from Gilead for marketing Tenofovir products in 95 developing and least developed countries. Aurobindo now has a total of 91 ANDA approvals (66 final approvals and 25 tentative approvals) from US FDA.

 
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