Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Fluoxetine Tabs 60 mg, from the United States Food & 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 ~US$ 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.
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