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Talvey
talquetamab-tgvs
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Talvey
Proper name
talquetamab-tgvs
Licence type
351(a)
BLA number
761342
Applicant
Janssen Biotech, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 3MG/1.5ML (2MG/ML) | Injection | Subcutaneous | Single-Dose Vial | Rx | August 9, 2023 |
| 40MG/ML | Injection | Subcutaneous | Single-Dose Vial | Rx | August 9, 2023 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | August 9, 2030 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |