Laurus Labs gets USFDA nod for HIV drug
Hyderabad: Laurus Labs Ltd has received approval from USFDA under President's Emergency Plan for AIDS Relief (PEPFAR) for two Abbreviated New Drug Applications for TLE 400 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/400mg) and TLE 600 (Tenofovir/ Lamivudine/ Efavirenz - 300/300/600mg) 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 - 300/300/400mg)
These approvals enable Laurus Labs to launch both the products in several LMIC markets.
Laurus Labs is an Indian pharmaceutical company headquartered in Hyderabad.
The Company's major focus areas include anti-retroviral, Hepatitis C and Oncology drugs.
Most of the Laurus Labs manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA, etc.