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.
