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
FDA authorised ANKTIVA on 22 April 2024
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 22 April 2024; FDA has authorised it.
ALTOR BIOSCIENCE, LLC, AN INDIRECT WHOLLY-OWNED SU holds the US marketing authorisation.