Shilpa Medicare Thursday said it has received tentative approval from the US health regulator for Dimethyl Fumarate delayed release capsules, used for treatment of relapsing forms of multiple sclerosis.
The company's abbreviated new drug application (ANDA) for Dimethyl Fumarate delayed release capsules in the strengths of 120 mg and 240 mg has been granted tentative approval by the United States Food and Drug Administration (USFDA), Shilpa Medicare said in a BSE filing.
Dimethyl Fumarate delayed release capsules is a generic of Tecfidera, it added.
Quoting IQVIA MAT second quarter 2018 data, Shilpa Medicare said the US market for Dimethyl Fumarate delayed release capsules is approximately USD 3.46 billion.
Shares of Shilpa Medicare were trading 3.92 per cent up at Rs 388.65 apiece on BSE.
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