Strides Receives USFDA Approval for Fluoxetine Tabs 60 mg: Expansion of Fluoxetine Portfolio

Monday, 16 September 2024, 03:01

Strides received USFDA approval for Fluoxetine Tabs 60 mg, enhancing access to this key medication. This approval signifies an important step for Strides in expanding its Fluoxetine portfolio.
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Strides Receives USFDA Approval for Fluoxetine Tabs 60 mg: Expansion of Fluoxetine Portfolio

Background on USFDA Approval

Strides Pharma Science has recently announced that its wholly owned subsidiary, Strides Pharma Global, Singapore, has received USFDA approval for Fluoxetine Tabs 60 mg. This medication is bioequivalent and therapeutically equivalent to TWi Pharmaceuticals' reference listed drug (RLD), Fluoxetine Tablets, 60 mg.

Market Implications

The approval of Fluoxetine Tabs 60 mg positions Strides to offer a complete range of Fluoxetine products, including Capsules and Tablets in 10 mg, 20 mg, and 60 mg strengths. The combined market size for Fluoxetine Capsules and Tablets is approximately US$ 130 million according to IMS data.

Dosing Flexibility

The introduction of the Fluoxetine Tabs 60 mg enhances dosing flexibility, meeting a broader spectrum of patient needs. Strides plans to launch all three strengths shortly, manufacturing the Fluoxetine tablets at its facility in Puducherry.


This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.


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