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US FDA approves Alembic Pharma’s generic antidepressant drug

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The approval is for generic Fluoxetine Hydrochloride, 10 mg and 20 mg tablets used for the treatment of depression and panic disorder

Alembic Pharmaceuticals received approval from the US health regulator for generic Fluoxetine Hydrochloride tablets used for the treatment of depression and panic disorder.

The approval is for the generic version of Eli Lilly and company’s Prozac tablets in the same strengths, Alembic Pharma said in a BSE filing.The company has received approval from the US Food and Drug Administration (USFDA) for its ANDA for Fluoxetine Hydrochloride tablets, 10 mg and 20 mg . These tablets have an estimated market size of $120 million for 12 months ending December 2015 according to IMS, the company added.

Alembic Pharma currently has a total of 53 ANDA approvals from the US health regulator.

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