Strides Pharma Science Ltd on Monday said its arm has received approval from the US health regulator for its generic version of antidepressant Fluoxetine tablets.
The approval granted by the US Food & Drug Administration (USFDA) to wholly owned subsidiary Strides Pharma Global Pte. Ltd, Singapore, is for Fluoxetine tablets of strength 60 mg, Strides Pharma Science said in a regulatory filing.
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine tablets, 60 mg, of TWi Pharmaceuticals, Inc, it added.
The Fluoxetine tablets will be manufactured at the company's facility in Puducherry, Strides said.
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, it added.
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The addition of the Fluoxetine tablets 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of patient needs, the company said, adding that it planned to launch all three strengths in the near future.
Fluoxetine is an antidepressant used for the treatment of major depressive disorder, obsessive compulsive disorder, Bulimia Nervosa and panic disorder.
Fluoxetine capsules and tablets have a combined market size of $130 million, the company said, citing IMS data.
