Strides receives USFDA approval for Fluoxetine Tabs 60 mg; Expanding the Product’s Availability Across Strengths
Date
9/17/2024 8:33:18 AM
(MENAFN- Adfactors PR) Bangalore, India, September 16, 2024 - Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, 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.
MENAFN17092024005232011781ID1108682689
Legal Disclaimer:
MENAFN provides the information “as is” without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the provider above.