Kedbumin Purple Book BLA 125384
- BLA number
- 125384
- Proprietary names
- Kedbumin
- Proper names
- Albumin (Human)
- Applicant
- Kedrion Biopharma Inc.
- Center
- CBER
- First observed release
- 2020-08-01
- 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 | Kedbumin | Albumin (Human) | 351(a) | 12.5G/50ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2011-06-03 | |
| 002 | Kedbumin | Albumin (Human) | 351(a) | 25G/100ML | Injection | Intravenous | Single-Dose Vial | Rx | Licensed | 2013-09-05 | |
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 |
|---|
| 2025-10-01 | U | 001 | Kedbumin | 351(a) | Rx | Kedrion Biopharma Inc. |
| 2025-10-01 | U | 002 | Kedbumin | 351(a) | Rx | Kedrion Biopharma Inc. |
| 2022-08-01 | U | 001 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
| 2022-08-01 | U | 002 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
| 2021-05-01 | U | 001 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
| 2021-05-01 | U | 002 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
| 2020-08-01 | R | 001 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
| 2020-08-01 | R | 002 | Kedbumin | 351(a) | Rx | Kedrion, S.p.A. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2020-08-01 | 001 | Kedbumin | 351(a) | Rx | Licensed | 2011-06-03 |
| 2020-08-01 | 002 | Kedbumin | 351(a) | Rx | Licensed | 2013-09-05 |