Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output

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.

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.