Strides Pharma Science’s subsidiary has gained approval from the US health regulator to market a generic antidepressant medication.

According to a regulatory filing, 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 USD 106 million, the Bengaluru-based firm said.

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

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with the 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 developing and manufacturing a wide range of IP-led niche pharmaceutical products.