Strides Pharma Science on Tuesday announced that its subsidiary has received approval from the US health regulator to market a generic antidepressant medication.
According to a regulatory filing, the company’s Singapore-based step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, has received approval for Fluoxetine Tabs (10 and 20 mg) from the US Food & Drug Administration (USFDA), the drug firm said in a regulatory filing.
The company’s product is therapeutically equivalent to Eli Lilly’s Prozac tablets. As per IMS, Fluoxetine tablets have a market size of USD 23.9 million.
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 USD106 million, the Bengaluru based firm said as quoted by PTI.
Fluoxetine is used for the treatment of major depressive disorder (MDD) and Obsessive Compulsive Disorder (OCD) among others.
