Drug firm Strides Shasun today said it has received approval from the US health regulator to market Ketoconazole tablets, used to treat fungal infections, in the American market.
Strides Pharma Global Pte, a wholly-owned subsidiary of the company, has received final approval from the US Food and Drug Administration (USFDA) for the product, Strides Shasun said in a statement.
The Bengaluru-based company's product is the generic version of Janssen Pharmaceutical's Nizoral tablets, which is indicated to treat certain serious fungal infections in the body.
As per IQVIA MAT April 2018 data, sales of Ketoconazole Tablets in the US market stood at around USD 7 million.
The company will manufacture the generic product at its oral dosage facility in Bengaluru. It will be marketed in the US market by Strides Pharma Inc.
The company claimed it has 75 cumulative abbreviated new drug applications (ANDA) filings with USFDA, of which 49 have been approved as of date and 26 are pending approval.
Shares of Strides Shasun were trading 1.75 per cent up at Rs 411.95 apiece on the BSE in the afternoon trade today.
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