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.