Zydus Lifesciences bags USFDA nod for hypotension injection Ephedrine Sulfate

Ahmedabad: Pharma major, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Ephedrine Sulfate Injection USP, 50 mg/mL single-dose vials (USRLD: Akovaz Injection).

Ephedrine Sulfate Injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

Hypotension is low blood pressure. Severely low blood pressure can deprive the brain and other vital organs of oxygen and nutrients, leading to a life-threatening condition called shock.

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The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India). Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States (IQVIA MAT Mar. 2023).

Medical Dialogues team had earlier reported that Zydus Cadila had received final approval from the USFDA to market Midodrine Hydrochloride Tablets (US RLD- ProAmatine Tablets) in the strengths of 2.5 mg, 5 mg, and 10 mg. The drug is used for certain patients who have symptoms of low blood pressure when standing. 

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Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. The group now has 368 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.