Laurus Labs receives USFDA approvals for two ANDAs under PEPFAR

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.