Wednesday, 23 August 2017

USFDA approval for Alembic Pharma

10 April 2017 | News | By Srinivas Rasoor

USFDA approval for Alembic Pharma

The US Food and Drug Administration has given approval to Alembic Pharmaceuticals for generic Fluoxetine Hydrochloride tablets used for the treatment of depression and panic disorder.
This drug is a generic version of Prozac tablets manufactured by Eli Lilly and Company.

Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company based in Gujarat. The company has a total of 53 abbreviated new drug application (ANDA) approval from the US health regulator.

Fluoxetine Hydrochloride tablets are prescribed for treating major depressive disorders and obsessive compulsive disorder in adult and paediatric patients. Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. It affects chemicals in the brain that may be unbalanced in people suffering from depression, panic, anxiety, or obsessive-compulsive symptoms.

The drug is available in the strengths of 10 and 20 mg. Common side effects associated with this drug include headache, dizziness, diarrhea, and weakness.

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