Drug firm Aurobindo Pharma said that it has received the final nod from the US health regulator for its generic anti-depressant Fluoxetine tablets.
The company has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and market Fluoxetine tablets in the strengths of 10 mg and 20 mg, Aurobindo Pharma said in a filing to BSE. The tablets are generic version of Eli Lilly’s Prozac tablets, it added.
The product will be launched in April 2020, Aurobindo Pharma said.
According to IQVIA, the approved product has an estimated market size of USD 42 million for the 12 months ending February 2020, it added.
Fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years, obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (OCD), and treatment of binge-eating and vomiting behaviours in adult patients with moderate to severe bulimia nervosa, Aurobindo Pharma said.
This is the first abbreviated new drug application (ANDA) to be approved out of APL Healthcare formulation facility in Hyderabad, used for manufacturing oral products, it added.
The company now has a total of 424 ANDA approvals (396 final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from US FDA, Aurobindo Pharma said.
Shares of Aurobindo Pharma were trading at Rs 470 per scrip on BSE, up 7.24 per cent from its previous close.