Strides Pharma Science arm gets USFDA nod for Fluoxetine Tabs
Fluoxetine is an antidepressant of the Selective Serotonin Reuptake Inhibitor class.
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-16 12:30 GMT | Update On 2024-09-16 12:30 GMT
Bangalore: Strides Pharma Science Limited 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, the Company stated in a BSE filing.
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.
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor- funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). The Company focuses on “difficult to manufacture” products sold in over 100 countries
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