Strides Pharma Science Limited (Strides) today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Fluoxetine Tabs 60 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Fluoxetine Tablets, 60 mg, of TWi Pharmaceuticals, Inc.
With the approval of the Fluoxetine Tabs 60 mg strength, the Company is now positioned to offer a complete portfolio of Fluoxetine across Capsules and Tablets in 10 mg, 20 mg, and 60 mg strengths. Fluoxetine Capsules and Tablets have a combined market size of ~US$ 130 Mn as per IMS.
The addition of the Fluoxetine Tabs 60 mg will allow for enhanced flexibility in dosing, catering to a broader spectrum of patient needs. The Company plans to launch all three strengths in the near future. The Fluoxetine tablets will be manufactured at the company's facility in Puducherry.
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.
Shares of Strides Pharma Science Limited was last trading in BSE at Rs. 1392.10 as compared to the previous close of Rs. 1353.50. The total number of shares traded during the day was 37666 in over 2631 trades.
The stock hit an intraday high of Rs. 1430.80 and intraday low of 1351.00. The net turnover during the day was Rs. 52564014.00. |
