Laurus Labs gets USFDA nod for generic antiretroviral drug

Laurus Labs gets USFDA nod for generic antiretroviral drug

227
USFDA
Picture: Pixabay

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.

Antiretroviral

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.

Also read: Phoenix Biotech stops business in Punjab and Haryana

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.

The Health Master is now on Telegram. For latest update on health and Pharmaceuticals, subscribe to The Health Master on Telegram.