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Aucatzyl
Obecabtagene autoleucel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Aucatzyl
Proper name
Obecabtagene autoleucel
Licence type
351(a)
BLA number
125813
Applicant
Autolus, Inc.
Center
CBER
Presentations
1
First licensure
November 8, 2024
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 410 10^6CAR+ T CELLS TOTAL; DELIVERED AS A SPLIT DOSE IN 3-5 BAGS ON DAY 1 & 10 | Suspension | Intravenous | Bag | Rx | November 8, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | November 8, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |