Rolvedon Purple Book BLA 761148
- BLA number
- 761148
- Proprietary names
- Rolvedon
- Proper names
- eflapegrastim-xnst
- Applicant
- Assertio Specialty Pharmaceuticals, LLC
- Center
- CDER
- First observed release
- 2022-09-01
- 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 | Rolvedon | eflapegrastim-xnst | 351(a) | 13.2MG/0.6ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | Licensed | 2022-09-09 | |
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 |
|---|
| 2026-03-01 | U | 001 | Rolvedon | 351(a) | Rx | Assertio Specialty Pharmaceuticals, LLC |
| 2026-02-01 | U | 001 | Rolvedon | 351(a) | Rx | Assertio Specialty Pharmaceuticals, LLC |
| 2022-09-01 | N | 001 | Rolvedon | 351(a) | Rx | Spectrum Pharmaceuticals, Inc. |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2022-09-01 | 001 | Rolvedon | 351(a) | Rx | Licensed | 2022-09-09 |