Strides gets USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg, from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly.

Fluoxetine tablets has a market size of ~$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 market size 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 USFDA, of which 245 ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

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.