Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 503.65 as compared to the previous close of Rs. 504.35. The total number of shares traded during the day was 26918 in over 1452 trades.

The stock hit an intraday high of Rs. 506.50 and intraday low of 502.00. The net turnover during the day was Rs. 13574136.00.

(*as of 31st December 2022)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals USFDA FinalApproval IsoproterenolHydrochloride