Strides Pharma announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte., Singapore, has received approval from the United States Food & Drug Administration (USFDA) for Fluoxetine Tablets 60 mg. The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine Tablets 60 mg, manufactured by TWi Pharmaceuticals, Inc.
With this approval, Strides Pharma is now positioned to offer a complete portfolio of Fluoxetine products across both Capsules and Tablets in 10 mg, 20 mg, and 60 mg strengths. Fluoxetine, an antidepressant, has a combined market size of approximately US$ 130 million, according to IMS.
The addition of the 60 mg Fluoxetine tablet is expected to offer more flexibility in dosing options, broadening its usage for diverse patient needs. Strides Pharma plans to launch all three strengths of Fluoxetine in the near future. The tablets will be manufactured at the company’s facility in Puducherry.
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