Prescription medicine
Nadofaragene firadenovec Brand names: Adstiladrin
Nadofaragene firadenovec (Adstiladrin) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nadofaragene firadenovec FDA label on DailyMed (effective March 24, 2026); every nadofaragene firadenovec label on DailyMed.
Highlights of the record
FDA label of March 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageADSTILADRIN ® 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.
Forms and strengths
Suspension.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 492 through July 30, 2026
What is nadofaragene firadenovec used for?
From the label: indications and usageADSTILADRIN ® 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. ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy 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.
Source: FDA drug label (ADSTILADRIN), Ferring Pharmaceuticals Inc., effective March 24, 2026 (SPL set 5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa), via openFDA; the full label on DailyMed
What does the patient leaflet for nadofaragene firadenovec say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ADSTILADRIN?Individuals who are immunosuppressed or immune-deficient should not prepare, administer, receive or come into contact with ADSTILADRIN.
Source: FDA drug label (ADSTILADRIN), Ferring Pharmaceuticals Inc., effective March 24, 2026 (SPL set 5ca20ed4-da4f-463c-ac2a-ccd6ab3774fa), via openFDA; the full label on DailyMed
Is there a generic for nadofaragene firadenovec (Adstiladrin)?
No generic nadofaragene firadenovec is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nadofaragene firadenovec?
The FDA Adverse Event Reporting System holds 492 reports that list nadofaragene firadenovec among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 25 are coded as a death and 33 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Nadofaragene firadenovec side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other