FDA — authorised 28 May 2010
- Application: NDA022555
- Marketing authorisation holder: PHOTOCURE ASA
- Local brand name: CYSVIEW KIT
- Indication: FOR SOLUTION — INTRAVESICAL
- Status: approved
FDA authorised Cysview Kit on 28 May 2010
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 May 2010; FDA has authorised it.
PHOTOCURE ASA holds the US marketing authorisation.