Strides Receives US FDA Approval for Fluoxetine Tabs 10 Mg & 20 Mg

Strides Receives US FDA Approval for Fluoxetine Tabs 10 Mg & 20 Mg

By, Admin 12 April 2024

Overview

Strides Pharma Science said that its step-down wholly owned subsidiary, Strides Pharma Global Pte.  Singapore, has received approval for fluoxetine tabs 10 mg and 20 mg, from the United States Food & Drug Administration (FDA).
 
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac  tablets of Eli Lilly.
 
Global Market Size

  • Fluoxetine tablets has a market size of ~US$ 23.9 million as per IMS. 
  • This approval further strengthens the company's presence in the fluoxetine portfolio, complementing the existing approval of fluoxetine capsules, which has a market size of US$106 million. 
  • The fluoxetine tablets will be manufactured at the company’s facility in Puducherry. 

 ANDA Filings

  • The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 245 ANDAs have been approved.
  • The company has set a target to launch ~ 60 new products over three years in the US.

Fluoxetine

  • Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. 
  • It is used for the treatment of major depressive disorder (MDD), obsessive–compulsive disorder (OCD), bulimia nervosa, panic disorder, with or without agoraphobia.

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