The US subsidiary of Glenmark Generics today said that they have been granted final abbreviated new drug application (ANDA) approval by the United States Food and Drug Administration (USFDA) for Lithium Carbonate 300 mg extended-release tablets. The company said that it will commence the marketing and distribution of the product immediately.
Lithium Carbonate 300 mg extended-release tablets are Glenmark's generic version of Lithobid by Noven Therapeutics which is indicated for manic episodes of bipolar disorder. According to IMS Health, the drug had total sales of $21 million for 12 months ending September. Glenmark will be one of the two generic players of this drug in the market.
Glenmark is currently authorised to distribute 66 products in the United States. The company said that it will maintain an aggressive ANDA filing strategy and will also explore partnerships to augment its portfolio.
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