Laurus Labs on Tuesday said it had received approval of the U.S. Food and Drug Administration (USFDA) for two Abbreviated New Drug Applications under PEPFAR (President’s Emergency Plan for AIDS Relief).
The approvals are for TLE 400 (Tenofovir/Lamivudine/ Efavirenz - 300/300/400mg) and TLE 600 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/600mg) tablets. A release from the company said Laurus Labs is one of the few players in the anti-retroviral segment to receive an approval for TLE 400 tablets, one of the most preferred regimens in the ARV first line treatment.
