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Reblozyl

luspatercept-aamt

351(a) Standalone BLA

Overview

Source: Purple Book

Proprietary name

Reblozyl

Proper name

luspatercept-aamt

Licence type

351(a)

BLA number

761136

Applicant

Celgene Corporation, a Bristol-Myers Squibb Company

Center

CDER

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
25MG/VIAL	For Injection	Subcutaneous	Single-Dose Vial	Rx	November 8, 2019
75MG/VIAL	For Injection	Subcutaneous	Single-Dose Vial	Rx	November 8, 2019

Exclusivity

Source: Purple Book

Kind	Expires
Orphan exclusivity	August 28, 2030

Sources for this page

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