Drug firm Laurus Labs on Tuesday 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 receivedapproval 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 Rs447.60per scrip on the BSE, up 5.13 per cent from its previous close.
Disclaimer: No Business Standard Journalist was involved in creation of this content
You’ve reached your limit of {{free_limit}} free articles this month.
Subscribe now for unlimited access.
Already subscribed? Log in
Subscribe to read the full story →
Smart Quarterly
₹900
3 Months
₹300/Month
Smart Essential
₹2,700
1 Year
₹225/Month
Super Saver
₹3,900
2 Years
₹162/Month
Renews automatically, cancel anytime
Here’s what’s included in our digital subscription plans
Exclusive premium stories online
Over 30 premium stories daily, handpicked by our editors
Complimentary Access to The New York Times
News, Games, Cooking, Audio, Wirecutter & The Athletic
Business Standard Epaper
Digital replica of our daily newspaper — with options to read, save, and share
Curated Newsletters
Insights on markets, finance, politics, tech, and more delivered to your inbox
Market Analysis & Investment Insights
In-depth market analysis & insights with access to The Smart Investor
Archives
Repository of articles and publications dating back to 1997
Ad-free Reading
Uninterrupted reading experience with no advertisements
Seamless Access Across All Devices
Access Business Standard across devices — mobile, tablet, or PC, via web or app