Zydus receives USFDA approval for Norepinephrine Bitartrate Injection

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

Norepinephrine Bitartrate is indicated for restoration of blood pressure in adult patients with acute hypotensive state. The drug will be manufactured at the group's topical injectable manufacturing facility at Jarod, India.

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

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