Strides Secures USFDA Approval for 60 mg Fluoxetine Tablets, Expanding Full Range of Dosages

Varahi Media.com online news,India, September 16, 2024:Strides Pharma Science Limited (Strides) announced that its subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval from the United States Food & Drug Administration (USFDA) for its Fluoxetine Tablets in the 60 mg strength.

This newly approved 60 mg tablet is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine Tablets, 60 mg, by TWi Pharmaceuticals, Inc.

With this approval, Strides now offers a comprehensive portfolio of Fluoxetine products, including Capsules and Tablets in 10 mg, 20 mg, and 60 mg dosages. According to IMS, the combined market for Fluoxetine Capsules and Tablets stands at approximately US$ 130 million.

By adding the 60 mg tablet, Strides enhances dosing flexibility to meet a wider range of patient needs. The company plans to launch all three strengths in the near future, with manufacturing to take place at its facility in Puducherry.

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