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Eugia Pharma Receives USFDA Approval for Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL Ampules

Published: July 07, 2020

Eugia Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL) Ampules.

Indications for this product include treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.

Refer to package insert for full prescribing information.