New Delhi: Aurobindo Pharma Limited is pleased to announce that the Company 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 US$ 42 million for the twelve months ending February 2020, according to IQVIA. 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 1st 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.
Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.438.25 as compared to the previous close of Rs. 445.5. The total number of shares traded during the day was 568722 in over 13741 trades.
