Strides Pharma Gets USFDA Approval for Antidepressant

New Delhi, Apr 9 (PTI) Strides Pharma Science on Tuesday said its subsidiary has received approval from the US health regulator to market a generic antidepressant medication.

The company's Singapore-based step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, has received approval for Fluoxetine Tabs (10 and 20 mg) from the US Food & Drug Administration (USFDA), the drug firm said in a regulatory filing.

The company's product is therapeutically equivalent to Eli Lilly's Prozac tablets.


As per IMS, Fluoxetine tablets have a market size of USD 23.9 million.

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 USD106 million, the Bengaluru based firm said.

Fluoxetine is used for the treatment of major depressive disorder (MDD) and Obsessive Compulsive Disorder (OCD) among others.