Zydus Lifesciences bags USFDA okay for Norepinephrine Bitartrate Injection
The drug will be manufactured at the group's topical injectable manufacturing facility at Jarod, India.;
Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), today announced that the company 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.
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.
Read also: USFDA nod to Zydus Efinaconazole Topical Solution
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). 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.
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