Omlyclo Purple Book BLA 761399
- BLA number
- 761399
- Proprietary names
- Omlyclo
- Proper names
- omalizumab-igec
- Applicant
- CELLTRION, Inc.
- Center
- CDER
- First observed release
- 2025-03-01
- 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 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 75MG/0.5ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-03-07 | |
| 002 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 150MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-03-07 | |
| 003 | Omlyclo | omalizumab-igec | 351(k) Interchangeable | 300MG/2ML (150MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2025-12-01 | |
Reference Biological Product#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103976 | Xolair | omalizumab | 351(a) | Rx | 2026-06-01 |
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 |
|---|
| 2025-12-01 | N | 003 | Omlyclo | 351(k) Interchangeable | Rx | CELLTRION, Inc. |
| 2025-03-01 | N | 001 | Omlyclo | 351(k) Interchangeable | Rx | CELLTRION, Inc. |
| 2025-03-01 | N | 002 | Omlyclo | 351(k) Interchangeable | Rx | CELLTRION, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2025-12-01 | 003 | Omlyclo | 351(k) Interchangeable | Rx | Licensed | 2025-12-01 |
| 2025-03-01 | 001 | Omlyclo | 351(k) Interchangeable | Rx | Licensed | 2025-03-07 |
| 2025-03-01 | 002 | Omlyclo | 351(k) Interchangeable | Rx | Licensed | 2025-03-07 |