Zydus Lifesciences wins FDA final approval for Isoproterenol HCL injection

Zydus Lifesciences has secured final approval for Isoproterenol Hydrochloride (HCL) Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) single-dose vials from the US Food and Drug Administration (FDA).

The approved product is a generic version of Isuprel Injection.

Isoproterenol hydrochloride injection has been approved for improving hemodynamic status in patients in distributive shock and shock caused by decreased cardiac output. It is also indicated for treating bronchospasm occurring when administered anesthesia.

Zydus Lifesciences will manufacture Isoproterenol hydrochloride injection at its injectable manufacturing facility in Jarod, near Vadodara.

As per IQVIA MAT February 2023, the annual sales of Isoproterenol Hydrochloride Injection USP, 0.2 mg/mL and 1 mg/5 mL (0.2 mg/mL) in the US were $28.5 million.

Zydus Lifesciences has 362 approvals now and to date filed more than 440 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.