ADSTILADRIN
STN: BLA 125700
Proper Name: nadofaragene firadenovec-vncg
Tradename: ADSTILADRIN
Manufacturer: Ferring Pharmaceuticals A/S
Indication:
- For the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
Product Information
Supporting Documents
- August 5, 2024 Approval Letter - ADSTILADRIN
- May 1, 2024 Approval Letter - ADSTILADRIN
- December 16, 2022 Approval Letter - ADSTILADRIN
- December 16, 2022 Summary Basis for Regulatory Action - ADSTILADRIN
- Approval History, Letters, Reviews and Related Documents - ADSTILADRIN