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Abecma

idecabtagene vicleucel

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Abecma
Proper name
idecabtagene vicleucel
Licence type
351(a)
BLA number
125736
Applicant
Celgene Corporation, a Bristol-Myers Squibb Company
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
300 to 460 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS Suspension Intravenous Bag Rx March 3, 2021
300 to 510 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS Suspension Intravenous Bag Rx April 4, 2024

Exclusivity

Source: Purple Book
Kind Expires
Orphan exclusivityApril 4, 1931

Sources for this page

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