FDA — authorised 22 April 2024
- Application: BLA761336
- Marketing authorisation holder: ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU
- Local brand name: ANKTIVA
- Indication: SOLUTION — INTRAVESICAL
- Status: approved
🇺🇸 N-803 in United States
FDA authorised N-803 on 22 April 2024 · 5 US adverse-event reports
Marketing authorisation
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 23 April 2025 – 23 April 2026
- Total reports: 5
Most-reported reactions
- Chills — 1 report (20%)
- Nausea — 1 report (20%)
- Neutropenia — 1 report (20%)
- Pyrexia — 1 report (20%)
- Toxicity To Various Agents — 1 report (20%)
N-803 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is N-803 approved in United States?
Yes. FDA authorised it on 22 April 2024.
Who is the marketing authorisation holder for N-803 in United States?
ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU holds the US marketing authorisation.