Skip to content

On this page

Ultomiris

ravulizumab-cwvz

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Ultomiris

Proper name

ravulizumab-cwvz

Licence type

351(a)

BLA number

761108

Applicant

Alexion Pharmaceuticals, Inc.

Center

CDER

Presentations

4

First licensure

—

Presentations

Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1,100MG/11ML (100MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	October 9, 2020
245MG/3.5ML (70MG/ML)	Injection	Subcutaneous	Single-Dose Cartridge	Rx	June 22, 2022
300MG/30ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	December 21, 2018
300MG/3ML (100MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	October 9, 2020

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	June 7, 2028

Sources for this page

Purple Book	FDA	Licence type, presentations, reference product, exclusivity