Strides Pharma Gets FDA Nod For Generic Antidepressant Fluoxetine 60 Mg Tablet

Strides Pharma Science Ltd. received approval from the US Food and Drug Administration for the generic antidepressant drug Fluoxetine. The nod was given to step-down wholly owned subsidiary Strides Pharma Global Pte., Singapore, according to a company statement on Monday.

The product is bioequivalent and therapeutically equivalent to the reference listed drug Fluoxetine tablets of 60 mg from Taiwan-based TWi Pharmaceuticals Inc. In simple terms, bioequivalent and therapeutically equivalent means generic drug.

Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor class and used for the treatment of major depressive disorder, obsessive-compulsive disorder, bulimia nervosa, panic disorder, with or without agoraphobia.

Strides Pharma said the approval of the Fluoxetine Tabs 60 mg now allows the company to offer a complete portfolio of the drug across capsules and tablets in the 10 mg, 20 mg, and 60 mg range. The company had received FDA approval in April for Fluoxetine 10 mg and 20 mg tablets as well as capsules.

Fluoxetine capsules and tablets have a combined market size of $130 million as per Intercontinental Medical Statistics, an American healthcare information and services provider.

"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 statement said.

The Bengaluru-based generic drugmaker will manufacture fluoxetine tablets at a facility in Puducherry.

The management has maintained its current year's US sales guidance of $285–300 million and $400 million by fiscal 2027. By the first quarter of next year, Strides Pharma targets to file two niche products (controlled substance or nasal spray), which would have a market size of $600–700 million each with the FDA.

Shares of Strides Pharma closed 2.81% higher at Rs 1,391.55 on the BSE after the announcement, compared to a 0.12% advance in the benchmark Sensex.