Aurobindo Pharma on Thursday said it has received the final approval from US Food and Drug Administration (USFDA) to manufacture and market Fluoxetine Tablets, 10 mg and 20 mg.
The product will be launched in April 2020. Fluoxetine tablets are generic version of Eli Lilly’s Prozac tablets and indicated for the acute and maintenance treatment of major depressive disorder.
The approved product has an estimated market size of $42 million for the twelve months ended February 2020, the company said citing IQVIA figures.
This is the first Abbreviated New Drug Application (ANDA) to be approved out of APL Healthcare formulation facility in Hyderabad. The facility is used for manufacturing oral products, a release from Aurobindo Pharma said.
