 "Glenmark gets tentative nod from USFDA to market prostate cancer drug")
Glenmark Pharmaceuticals has received tentative nod from the US health regulator for Abiraterone Acetate tablets, used in the treatment of prostate cancer.
Glenmark Pharmaceuticals Inc USA has been granted tentative approval by the United States Food and Drug Administration for Abiraterone Acetate tablets USP in the strength of 250 mg, the company said in a BSE filing on Wednesday.
The approved product is a generic version of Janssen Biotech Inc's Zytiga tablets.
Quoting IQVIA sales data for the 12-month period ended November 2018, Glenmark Pharmaceuticals said, Zytiga tablets 250 mg market achieved annual sales of approximately $1.3 billion.
The company's current portfolio consists of 148 products authorised for distribution in the US market and 54 abbreviated new drug applications (ANDAs) pending approval with the USFDA.
Shares of Glenmark Pharmaceuticals were trading 1.17 per cent lower at Rs 648.45 apiece 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