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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