Laurus Labs gets USFDA nod for generic antiretroviral drug
New Delhi: Drug firm Laurus Labs said it has received approval from the US health regulator for its applications for generic antiretroviral fixed dose combination drugs — TLE 400 and TLE 600. The company has received approval from US Food and Drug Administration (USFDA) under PEPFAR (President’s Emergency Plan for AIDS Relief) for two abbreviated new drug applications for TLE 400 and TLE 600 tablets, Laurus Labs said in a BSE filing.
The company is one of the few players in the antiretroviral (ARV) segment to receive an approval for TLE 400 tablets. It is one of the most preferred regimens in the ARV first line treatment, it added.
Laurus Labs has already received WHO pre-qualification for TLE 400, the filing said. These approvals enables the company to launch both the products in several low and middle-income countries, it added.
Shares of Laurus labs were trading at Rs 447.60 per scrip on the BSE, up 5.13 per cent from its previous close.