 "Lupin's prophylaxis and chronic asthma treatment drug gets USFDA nod")
Domestic pharma firm Lupin on Friday said it has received approval from the US health regulator for its generic Zileuton extended-release tablets used as prophylaxis and in treatment of chronic asthma.
The approval by the US Food and Drug Administration (USFDA) is for Zileuton extended-release tablets of strength 600 mg, which is the generic equivalent of Zyflo CR of Chiesi USA, Inc, Lupin said in a regulatory filing.
The medicine is indicated for prophylaxis and treatment of chronic asthma in adults and children 12 years of age and older, it added.
Citing IQVIA MAT September 2019 data, the company said Zileuton extended-release tablets, 600 mg had annual sales of approximately $43 million in the US.
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