BEQVEZ Purple Book BLA 125786
- BLA number
- 125786
- Proprietary names
- BEQVEZ
- Proper names
- fidanacogene elaparvovec-dzkt
- Applicant
- Pfizer Inc.
- Center
- CBER
- First observed release
- 2024-05-01
- 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 | BEQVEZ | fidanacogene elaparvovec-dzkt | 351(a) | 1x E13 VG/ML | Suspension | Intravenous | Single-Dose Vial | Disc | Voluntarily Revoked | 2024-04-25 | |
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 |
|---|
| 2025-08-01 | U | 001 | BEQVEZ | 351(a) | Disc | Pfizer Inc. |
| 2024-08-01 | U | 001 | BEQVEZ | 351(a) | Rx | Pfizer Inc. |
| 2024-06-01 | U | 001 | BEQVEZ | 351(a) | Rx | Pfizer Inc. |
| 2024-05-01 | N,U | 001 | BEQVEZ | 351(a) | Rx | Pfizer Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-08-01 | 001 | BEQVEZ | 351(a) | Disc | Voluntarily Revoked | 2024-04-25 |
| 2024-06-01 | 001 | BEQVEZ | 351(a) | Rx | Licensed | 2024-04-25 |
| 2024-05-01 | 001 | BEQVEZ | 351(a) | Rx | Licensed | 2024-04-25 |