Adstiladrin Purple Book BLA 125700
- BLA number
- 125700
- Proprietary names
- Adstiladrin
- Proper names
- nadofaragene firadenovec-vncg
- Applicant
- Ferring Pharmaceuticals A/S
- Center
- CBER
- First observed release
- 2022-12-01
- 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 | Adstiladrin | nadofaragene firadenovec-vncg | 351(a) | 3x10^11 viral particles (vp)/mL | For Suspension | Intravesical | Single-Dose Vial | Rx | Licensed | 2022-12-16 | |
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 |
|---|
| 2023-08-01 | U | 001 | Adstiladrin | 351(a) | Rx | Ferring Pharmaceuticals A/S |
| 2023-07-01 | U | 001 | Adstiladrin | 351(a) | Disc | Ferring Pharmaceuticals A/S |
| 2023-04-01 | U | 001 | Adstiladrin | 351(a) | Rx | Ferring Pharmaceuticals A/S |
| 2022-12-01 | N | 001 | Adstiladrin | 351(a) | Rx | Ferring Pharmaceuticals A/S |
Observed Product State History#
Release, Product, Name table| Release | Product | Name | License type | Marketing | Licensure | Approval |
|---|
| 2023-08-01 | 001 | Adstiladrin | 351(a) | Rx | Licensed | 2022-12-16 |
| 2023-07-01 | 001 | Adstiladrin | 351(a) | Disc | Licensed | 2022-12-16 |
| 2022-12-01 | 001 | Adstiladrin | 351(a) | Rx | Licensed | 2022-12-16 |