Aurobindo Pharma gets USFDA nod for Fluoxetine Tablets
Hyderabad: Aurobindo Pharma Limited has announced 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 a 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 1 st ANDA to be approved out of the 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.
Aurobindo Pharma Limited, headquartered at Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients.
The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's product portfolio is spread over major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and AntiDiabetics, supported by an outstanding R&D set-up.