The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Prozac Tablets of Eli Lilly.

Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used for the treatment of major depressive disorder (MDD), obsessive–compulsive disorder (OCD), bulimia nervosa, panic disorder, with or without agoraphobia. Fluoxetine Tablets have a market size of approximately $23.9 million, as per IMS.

This approval further strengthens the company's presence in the Fluoxetine portfolio, complementing the existing approval of Fluoxetine capsules, which has a marketsize of $106 million. The Fluoxetine Tablets will be manufactured at the company’s facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 245 ANDAs have been approved. The company has set a target to launch nearly 60 new products over three years in the US.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

The firm reported consolidated net profit of Rs 49.67 crore in Q3 FY24 as against a net loss of Rs 80.03 crore posted in Q3 FY23. The company recorded quarterly sales of Rs 1,038.9 crore in Q3 FY24, registering a growth of 19.60% from Rs 868.6 crore in Q3 FY23.

The scrip rose 0.09% to currently trade at Rs 846.35 on the BSE.