Aurobindo receives USFDA approval for Fluoxetine tablets

Aurobindo Pharma Limited has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fluoxetine tablets, 10 mg and 20 mg. Fluoxetine tablets are generic version of Eli Lilly’s Prozac tablets. The product will be launched in April 2020. The approved product has an estimated market size of USD 42 million for the 12 months ending February 2020. 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 behaviors in adult patients with moderate to severe bulimia nervosa. This is the first ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India, used for manufacturing oral products. Aurobindo now has a total of 424 ANDA approvals (396 final approvals including 22 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.