ADSTILADRIN

STN: BLA 125700
Proper Name: nadofaragene firadenovec-vncg
Tradename: ADSTILADRIN
Manufacturer: Ferring Pharmaceuticals A/S
Indication: 

• ADSTILADRIN is indicated 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

• Package Insert - ADSTILADRIN

Supporting Documents

• October 9, 2025 Approval Letter - ADSTILADRIN
• 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