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Altuviiio

antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Altuviiio

Proper name

antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl

Licence type

351(a)

BLA number

125771

Applicant

Bioverativ Therapeutics, Inc.

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	February 22, 2023
2000IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023
250IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023
3000IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023
4000IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023
500IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023
750IU	For Injection	Intravenous	Single-Dose Vial	Rx	February 22, 2023

Source: Purple Book

Kind	Expires
Orphan exclusivity	February 22, 2030

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