Columvi Purple Book BLA 761309
- BLA number
- 761309
- Proprietary names
- Columvi
- Proper names
- glofitamab-gxbm
- Applicant
- Genentech, Inc.
- Center
- CDER
- First observed release
- 2023-06-01
- Latest observed release
- 2026-06-01
- Newest archive release
- 2026-06-01
- FDA patent list
- No patents listed in the captured FDA patent list; source updated 2025-06-11
- Coverage
- Present in newest release
Latest Known Product Presentations#
Product, Proprietary name, Proper name table| Product | Proprietary name | Proper name | License type | Strength | Dosage form | Route | Presentation | Marketing | Licensure | Approval | Patent list provided |
|---|
| 001 | Columvi | glofitamab-gxbm | 351(a) | 2.5MG/2.5ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2023-06-15 | |
| 002 | Columvi | glofitamab-gxbm | 351(a) | 10MG/10ML (1MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2023-06-15 | |
Published Patent List#
No patents for this BLA were listed in the FDA Purple Book patent list captured from the source updated 2025-06-11.
Official Monthly Change Events#
Release, Event, Product table| Release | Event | Product | Name | License type | Status | Applicant |
|---|
| 2023-06-01 | N | 001 | Columvi | 351(a) | Rx | Genentech, Inc. |
| 2023-06-01 | N | 002 | Columvi | 351(a) | Rx | Genentech, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-06-01 | 001 | Columvi | 351(a) | Rx | Licensed | 2023-06-15 |
| 2023-06-01 | 002 | Columvi | 351(a) | Rx | Licensed | 2023-06-15 |