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Idelvion

Coagulation Factor IX (Recombinant), Albumin Fusion Protein

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Idelvion

Proper name

Coagulation Factor IX (Recombinant), Albumin Fusion Protein

Licence type

351(a)

BLA number

125582

Applicant

CSL Behring Lengnau AG

Center

CBER

Presentations

First licensure

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Source: Purple Book

Every strength and presentation recorded in the Purple Book for this product.
Strength	Dosage form	Route	Presentation	Status	Licensed
1000IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 4, 2016
2000IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 4, 2016
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 4, 2016
3500IU	For Injection	Intravenous	Single-Dose Vial	Rx	May 30, 2018
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	March 4, 2016

Source: Purple Book

Kind	Expires
Orphan exclusivity	March 4, 2023

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