Aurobindo gets tentative nod for Emtricitabine / Tenofovir Disproxil Fumarate Tablets

March 31, 2009 by admin  

Aurobindo Pharma has received the tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market its anti-AIDS combination drug Emtricitabine / Tenofovir Disproxil Fumarate Tablets 200mg / 300mg.

The drug, which falls under the Anti-Retroviral (ARV) segment, is the generic equivalent of Gilead Sciences Inc Truvada tablets 200mg / 300mg and. It is indicated in combination with other ARV agents for the treatment of HIV-1 infection in adults.

Following this, the company now has a total of 95 ANDA approvals from USFDA. This includes 68 final approvals and 27 tentative approvals.

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