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Tecvayli
teclistamab-cqyv
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Tecvayli
Proper name
teclistamab-cqyv
Licence type
351(a)
BLA number
761291
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 153MG/1.7ML (90MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | October 25, 2022 |
| 30MG/3ML (10MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | October 25, 2022 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | October 25, 2029 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |