Drug firm Aurobindo Pharma on Thursday said it has received the final nod from the US health regulator for its generic anti-depressant Fluoxetine tablets.
The company has received the final approval from the US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine tablets in the strengths of 10 mg and 20 mg, Aurobindo Pharma said in a filing to BSE.
The tablets are generic version of Eli Lilly's Prozac tablets, it added.
The product will be launched in April 2020, Aurobindo Pharma said.
According to IQVIA, the approved product has an estimated market size of USD 42 million for the 12 months ending February 2020, it added.
Fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years, obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (OCD), and treatment of binge-eating and vomiting behaviours in adult patients with moderate to severe bulimia nervosa, Aurobindo Pharma said.
This is the first abbreviated new drug application (ANDA) to be approved out of APL Healthcare formulation facility in Hyderabad, used for manufacturing oral products, it added.
The company now has a total of 424 ANDA approvals (396 final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA, Aurobindo Pharma said.
Shares of Aurobindo Pharma were trading at Rs 470 per scrip on BSE, up 7.24 per cent from its previous close.
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
