Supply: Strides Pharma Fb
Strides Pharma Science Ltd on Monday mentioned its arm has obtained approval from the US well being regulator for its generic model of antidepressant Fluoxetine tablets.
The approval granted by the US Meals & Drug Administration (USFDA) to wholly owned subsidiary Strides Pharma World Pte. Ltd, Singapore, is for Fluoxetine tablets of energy 60 mg, Strides Pharma Science mentioned in a regulatory submitting.
The product is bioequivalent and therapeutically equal to the reference listed drug (RLD), Fluoxetine tablets, 60 mg, of TWi Prescribed drugs, Inc, it added.
The Fluoxetine tablets shall be manufactured on the firm’s facility in Puducherry, Strides mentioned.
With the approval of the Fluoxetine Tabs 60 mg energy, the corporate is now positioned to supply a whole portfolio of Fluoxetine throughout capsules and tablets in 10 mg, 20 mg, and 60 mg strengths, it added.
The addition of the Fluoxetine tablets 60 mg will permit for enhanced flexibility in dosing, catering to a broader spectrum of affected person wants, the corporate mentioned, including that it deliberate to launch all three strengths within the close to future.
Fluoxetine is an antidepressant used for the remedy of main depressive dysfunction, obsessive compulsive dysfunction, Bulimia Nervosa and panic dysfunction.
Fluoxetine capsules and tablets have a mixed market dimension of USD 130 million, the corporate mentioned, citing IMS knowledge.
(Solely the headline and movie of this report might have been reworked by the Enterprise Customary employees; the remainder of the content material is auto-generated from a syndicated feed.)
First Printed: Sep 16 2024 | 6:54 PM IST
