Strides Pharma Science Limited has announced that its step-down subsidiary, Strides Pharma Global Pte. Limited (Singapore), has secured approval from the United States Food & Drug Administration (USFDA) for Fluoxetine Tablets in the 60 mg dosage. This development complements the company’s recent approvals for Fluoxetine 10 mg and 20 mg tablets, as well as Fluoxetine capsules, positioning Strides to offer a comprehensive range of strengths across both tablet and capsule forms.

The newly approved Fluoxetine 60 mg tablets are bioequivalent and therapeutically equivalent to the reference listed drug by TWi Pharmaceuticals, Inc. With this addition, Strides strengthens its market presence in the Fluoxetine segment, a widely prescribed antidepressant classified under Selective Serotonin Reuptake Inhibitors (SSRIs), used to treat conditions such as Major Depressive Disorder (MDD), Obsessive-Compulsive Disorder (OCD), Bulimia Nervosa, and Panic Disorder.

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Fluoxetine capsules and tablets together account for a market size of approximately USD 130 million, according to IMS data. The company plans to launch the newly approved strength alongside its 10 mg and 20 mg variants soon. All strengths of Fluoxetine tablets will be manufactured at Strides’ facility in Puducherry, India.

This latest approval highlights Strides’ commitment to delivering high-quality pharmaceutical solutions, catering to diverse patient needs with increased dosing flexibility.

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