Strides Pharma Science Singapore arm gets USFDA nod for Major Depressive Disorder drug Fluoxetine
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug Prozac Tablets of Eli Lilly.
Bangalore: Strides Pharma Science Limited has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg, from the United States Food & Drug Administration (USFDA).
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.
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly.
Fluoxetine tablets has a market size of ~US$ 23.9 Mn 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 marketsize of US$106 Mn," the Company stated.
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The Fluoxetine tablets will be manufactured at the company’sfacility in Puducherry. The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245 ANDAs have been approved.
The company has set a target to launch ~ 60 new products over three years in the US, as per the release.
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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).
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