J B Chemicals and Pharmaceuticals on Monday said it has received approval from the US health regulator to market Carbamazepine extended release tablets used in the treatment of epilepsy.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Carbamazepine extended release tablets in strengths of USP 100 mg, 200 mg and 400 mg, J B Chemicals and Pharmaceuticals said in a regulatory filing.
The company's product is indicated for treatment of epilepsy and trigeminal neuralgia and is the generic version of Novartis Pharmaceuticals' Tegretol XR tablets.
"The company plans to commercialise this product in third quarter of this financial year and is expected to boost the company's US sales," J B Chemicals and Pharmaceuticals said.
As per IQVIA data, US sales of the product stood at around USD 128 million.
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