USFDA Approves Strides Pharma's Generic Fluoxetine Tablets

Strides Pharma Science Ltd's subsidiary received USFDA approval for its generic Fluoxetine tablets (60 mg). These tablets are equivalent to TWi Pharmaceuticals' version. Strides Pharma will produce them in Puducherry, offering a full range of Fluoxetine in different strengths. This enhances dosing flexibility for various patient needs.

Strides Pharma Science Ltd announced on Monday that its subsidiary has secured approval from the US health regulator for its generic Fluoxetine tablets.

The United States Food & Drug Administration (USFDA) authorized Strides Pharma Global Pte. Ltd, Singapore, to produce 60 mg Fluoxetine tablets, as confirmed in a regulatory filing by Strides Pharma Science.

This product is bioequivalent and therapeutically equivalent to the 60 mg Fluoxetine tablets by TWi Pharmaceuticals, Inc. Production will occur at Strides' Puducherry facility.

With the new approval, Strides can now offer Fluoxetine in 10 mg, 20 mg, and 60 mg tablet strengths, addressing broader patient needs. The launch of these products is anticipated soon.

Fluoxetine is an antidepressant used for treating major depressive disorder, obsessive compulsive disorder, Bulimia Nervosa, and panic disorder. The combined market for Fluoxetine capsules and tablets stands at USD 130 million, based on IMS data.

(With inputs from agencies.)