Aurobindo gets nod for HIV drug

Aurobindo Pharma Ltd has received tentative approval for Tenofovir Disoproxil Fumarate tablets in 300 mg dosage from the US Food & Drug Administration (USFDA). It is the generic equivalent of Gilead Sciences Inc. Viread tablets 300 mg and falls under the Anti-Retroviral (ARV) segment.
 
The drug is indicated in combination with other ARVs for the treatment of HIV-I infection in adults. The Abbreviated New Drug Application (ANDA) was reviewed under the expedited provisions of the President’s Emergency Plan for AIDS relief (PEPFAR) in the US. 
 
Aurobindo has obtained licence from Gilead for marketing Tenofovir products in 95 developing and least developed countries. So far the Hyderabad-based pharma major has a total of 921 ANDA approvals (66 final and 25 tentative) from the USFDA.