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Adakveo

crizanlizumab-tmca

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Adakveo

Proper name

crizanlizumab-tmca

Licence type

351(a)

BLA number

761128

Applicant

Novartis Pharmaceuticals Corporation

Center

CDER

Presentations

1

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
100MG/10ML (10MG/ML)	Injection	Intravenous	Single-Dose Vial	Rx	November 15, 2019

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 15, 2026

Sources for this page

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