Aurobindo Pharma gets tentative approval for Tenofovir

Aurobindo Pharma has received the tentative approval for Tenofovir Disoproxil Fumarate Tablets, 300mg from the US Food & Drug Administration (USFDA).

Tenofovir Disoproxil Fumarate Tablets, 300mg is the generic equivalent of Gilead Sciences Inc’s Viread tablets 300 mg and falls under the Anti-Retroviral (ARV) segment.

It is used 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 USFDA.