Skip to content

On this page

Adzynma

ADAMTS13, recombinant-krhn

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Adzynma

Proper name

ADAMTS13, recombinant-krhn

Licence type

351(a)

BLA number

125795

Applicant

Takeda Pharmaceuticals U.S.A., Inc.

Center

CBER

Presentations

2

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
1500IU	For Injection	Intravenous	Single-Dose Vial	Rx	November 9, 2023
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	November 9, 2023

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	November 9, 2030

Sources for this page

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