Zydus receives USFDA final approval for Chlorpromazine Hydrochloride Injection
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), Single-Dose Vials, (RLD: Thorazine Injection).
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders (such as schizophrenia, psychotic disorders, manic phase of bipolar disorder, severe behavioral problems in children). It is also used to control nausea/vomiting, relieve prolonged hiccups, relieve restlessness/anxiety before surgery, treat a certain liver problem (porphyria), and help treat tetanus. The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara (India).
Chlorpromazine Hydrochloride Injection USP, 25 mg/mL and 50 mg/2 mL (25 mg/mL), Single-Dose Vials, had annual sales of USD 12.5 mn. in the United States (IQVIA MAT Jan24).
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