Friday, 7 April 2017


Vadodara-headquartered Alembic Pharma on Friday received USFDA approval for its ANDA for Fluoxetine Hydrochloride tablets. The tablets of 10mg and 20mg received the approval.

The tablets have forecasted market size of 120 million USD for 12 months ended December 2015. Alembic’s ANDA approvals stand at 53, 47 final and 6 tentative approvals.

The stock of Alembic Pharma surged 1.65% to 630 from 612 level at which it was trading just before the announcement. The approved ANDA is therapeutically equivalent to the drug, Prozac tablets of 10mg and 20mg produced by Eli Lilly and Company.

The Fluoxetine tablets are used for treatment of major depressive disorder and obsessive compulsive disorder in adult and paediatric patients. It can be also used for treatment binge eating, vomiting behaviour in bulimia nervosa and acute treatment of panic disorder in adult.

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