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Laurus Labs Ltd has received approval from the US Food and Drug Administration (USFDA) for two Abbreviated New Drug Applications (ANDAs ) for Tenofovir/ Lamivudine/ Efavirenz (TLE) for 400 mg and 600 mg tablets.
The approval has been given under the President’s Emergency Plan for AIDS Relief (PEPFAR), the Hyderabad-based company said in a release on Tuesday.
Laurus Labs is one of the few players in the ARV segment to receive approval for TLE 400 mg. It is “one of the most preferred regimens in the ARV first line treatment,” the company said.
Laurus has already received WHO pre-qualification for the same.
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