FDA — authorised 15 November 2023
- Application: NDA214520
- Marketing authorisation holder: CORMEDIX
- Local brand name: DEFENCATH
- Indication: SOLUTION — N/A
- Status: approved
FDA authorised Taurolidine and Heparin on 15 November 2023
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 November 2023; FDA has authorised it.
CORMEDIX holds the US marketing authorisation.