Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Hydrochloride Tablets, 10 mg and 20mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Prozac Tablets, 10 mg and 20mg, of Eli Lilly and Company.
Fluoxetine Hydrochloride Tablets are indicated for the treatment of Major Depressive Disorder (MDD) and Obsessive Compulsive Disorder (OCD) in adult and pediatric patients. Fluoxetine Tablets are also indicated for treatment of binge eating and vomiting behaviour in moderate to severe Bulimia Nervosa and acute treatment of Panic Disorder, in adult patients.
Fluoxetine Hydrochloride Tablets have an estimated market size of $120 million for twelve months ending December 2015. Alembic now has a total of 53 ANDA approvals (47 final approvals and 6 tentative approvals) from the USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.