Aurobindo Pharma has received tentative approval from the US Food & Drug Administration (USFDA) to manufacture and market its anti-AIDS combination drug Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg.
Efavirenz / Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 600mg/200mg/300mg is the generic equivalent of Gilead Sciences Inc’s Atripla Tablets 600mg/200mg/300mg and falls under the Anti-Retroviral (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 now has a total of 182 ANDA approvals (156 Final approvals including 2 from Aurolife Pharma LLC and 26 Tentative approvals) from USFDA.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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