🇺🇸 Elexacaftor, Tezacaftor, Ivacaftor in United States

Elexacaftor, Tezacaftor, Ivacaftor (Elexacaftor, Tezacaftor, Ivacaftor) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Elexacaftor, Tezacaftor, Ivacaftor in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Elexacaftor, Tezacaftor, Ivacaftor approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Elexacaftor, Tezacaftor, Ivacaftor in United States?

Meyer Children's Hospital IRCCS is the originator. The local marketing authorisation holder may differ — check the official source linked above.