Zydus Lifesciences bags USFDA okay for Isoproterenol Hydrochloride Injection
Ahmedabad: Drugmaker, Zydus Lifesciences Limited, has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials (USRLD: Isuprel Injection).
Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output and for treatment of bronchospasm occurring during anaesthesia.
The drug will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara (India).
Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) had annual sales of USD 28.5 mn in the United States (IQVIA MAT Feb. 2023). The group now has 362 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
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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.
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