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Laurus Labs receives USFDA approvals for two ANDAs under PEPFAR

expresspharmaMay 20, 2020

Tag: Laurus Labs , FDA , ANDA , TLE 400

Laurus Labs has received approval from USFDA under President’s Emergency Plan for AIDS Relief (PEPFAR) for two Abbreviated New Drug Application (ANDAs) TLE400 (Tenofovir/ Lamivudine/ Efavirenz – 300/300/400 mg) and TLE600 (Tenofovir/ Lamivudine/ Efavirenz – 300/300/600 mg) tablets.

Laurus Labs is one of the few players in the ARV segment to receive approval for TLE 400 tablets. TLE 400 is one of the most preferred regimens in the ARV first-line treatment. The Company already received WHO Pre-Qualification for TLE 400 (Tenofovir/ Lamivudine/ Efavirenz – 300/300/400 mg).

These approvals enable Laurus Labs to launch both the products in several LMIC markets.


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