🇺🇸 Arikayce in United States

FDA authorised Arikayce on 28 September 2018

Marketing authorisations

FDA — authorised 28 September 2018

  • Application: NDA207356
  • Marketing authorisation holder: INSMED INC
  • Status: supplemented

FDA

  • Status: approved

Arikayce in other countries

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

Other Other approved in United States

Frequently asked questions

Is Arikayce approved in United States?

Yes. FDA authorised it on 28 September 2018; FDA has authorised it.

Who is the marketing authorisation holder for Arikayce in United States?

INSMED INC holds the US marketing authorisation.