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Carvykti
ciltacabtagene autoleucel
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Carvykti
Proper name
ciltacabtagene autoleucel
Licence type
351(a)
BLA number
125746
Applicant
Janssen Biotech, Inc.
Center
CBER
Presentations
1
First licensure
February 28, 2022
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion | For Injection | Intravenous | Bag | Rx | February 28, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | April 5, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |