Zydus gets final USFDA approval for Norepinephrine Bitartrate Injection

21 Jul 2022 , 12:26 PM

Zydus Lifesciences Limited has received final United States Food and Drug Administration (USFDA) approval to market Norepinephrine Bitartrate Injection USP,4 mg/4 mL (1 mg/mL) Single-Dose Vial. (USRLD: Levophed).

According to the regulatory filing, Norepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state. 

Further, the drug will be manufactured at the group’s topical injectable manufacturing facility located at Jarod, India.

 According to IQVIA data, Norepinephrine Bitartrate Injection USP, 1mg/1 mL had annual sales of US$ 63.8 million in the United States (IQVIA MAT May 2022).

Since the commencement of the filing process in FY 2003-04, the group now has 317 approvals and has so far filed over 420 ANDAs.

At around 12:30 PM, Zydus Lifesciences was trading at Rs357.80 per share down by Rs0.9 or 0.25% from its previous closing of Rs358.70 per share on the BSE.