Sun Pharmaceutical Industries today said it has got tentative approval from the US drug regulator for generic Gleevec (imatinib meyslate tablets), used in the treatment of chronic myeloid leukaemia.
The US Food and Drug Administration (USFDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) for generic Gleevec, Sun Pharma said in a filing to the Bombay Stock Exchange (BSE).
The tentatively approved drug (imatinib meyslate tablets) is therapeutically equivalent to Gleevec tablets of Novartis.
The approval of imatinib mesylate tablets are in the strengths of 100 mg and 400 mg.
The annual sales of these tablets are about 950 million dollars in the US.
Shares of Sun Pharmaceutical were trading at Rs 1,451.90, down 1.74 per cent in the morning trade on the BSE.
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