Strides has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Ltd., Singapore, has received approval for Fluoxetine Tabs 60 mg, from the United States Food and Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine Tablets, 60 mg, of TWi Pharmaceuticals, Inc.

With the approval of the Fluoxetine Tabs 60 mg strength, the company is now positioned to offer a complete portfolio of Fluoxetine across Capsules and Tablets in 10 mg, 20 mg, and 60 mg strengths. Fluoxetine Capsules and Tablets have a combined market size of ~USD 130 Mn as per IMS.

The addition of the Fluoxetine Tabs 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of patient needs. The company plans to launch all three strengths in the near future. The Fluoxetine tablets will be manufactured at the company’s facility in Puducherry.

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.

Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE and National Stock Exchange of India Ltd. (STAR). The company mainly operates in the regulated markets and has an 'in Africa for Africa' strategy and an institutional business to service donor-funded markets.