Zydus Lifesciences receives final approval from USFDA for Norepinephrine Bitartrate Injection

21 Jul 2022 Evaluate

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 $63.8 million in the United States according to IQVIA data (IQVIA MAT May 2022). The group now has 317 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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