Strides Pharma Science gets FDA approval for Fluoxetine Tablets for depressive disorders

Strides Pharma Science Limited (Strides) has made a notable advancement in the field of mental health treatment by securing approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine Tablets 10 mg and 20 mg. This development is significant for Strides’ subsidiary, Strides Pharma Global Pte. Limited, Singapore, positioning the company as a prominent player in the pharmaceutical sector, particularly in the treatment of major depressive disorders.

The approved Fluoxetine Tablets are bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Prozac® Tablets by Eli Lilly, a benchmark in the treatment of depression and related disorders. With a market size of approximately US$ 23.9 million, according to IMS data, this approval significantly enhances Strides’ footprint in the Fluoxetine portfolio, complementing its existing Fluoxetine capsules, which hold a market size of US$106 million.

Manufactured in the company’s facility in Puducherry, the addition of Fluoxetine Tablets to Strides’ portfolio underlines its commitment to addressing the comprehensive needs of individuals suffering from depression and anxiety disorders. Fluoxetine is recognized for its effectiveness in treating Major Depressive Disorder (MDD), Obsessive–Compulsive Disorder (OCD), Bulimia Nervosa, and Panic Disorder, among others, showcasing its versatility as a Selective Serotonin Reuptake Inhibitor (SSRI).

Strides Pharma Science Limited boasts an impressive portfolio of 260 cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA, including 245 approved ANDAs. This achievement is part of the company’s strategic initiative following the acquisition of a portfolio from Endo at Chestnut Ridge. Strides has set an ambitious target to launch approximately 60 new products in the US market over the next three years, further solidifying its position as a key player in the global pharmaceutical industry.

The USFDA approval of Fluoxetine Tablets for Strides Pharma Science Limited marks a critical milestone in the pharmaceutical industry’s efforts to combat mental health issues. This approval not only expands the treatment options available for individuals with depressive and anxiety disorders but also emphasizes the importance of continued innovation and development in the field of mental health medication. Strides’ ongoing commitment to enhancing its product offerings and its significant investments in research and development are testament to the vital role the pharmaceutical industry plays in improving patient care and treatment outcomes.