The USFDA has given Zydus Lifesciences final approval to manufacture and market Isoproterenol Hydrochloride Injection in 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials. According to the Zyuds statement, isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients with distributive shock and shock due to decreased cardiac output, as well as to treat bronchospasm during anaesthesia.
The drug will be manufactured at Zydus’ injectable manufacturing facility in Jarod, near Vadodara (India). In the United States, isoproterenol hydrochloride injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) had annual sales of USD 28.5 million (IQVIA MAT Feb. 2023).