🇺🇸 Tyvaso® in United States

Tyvaso® (Tyvaso®) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Tyvaso® 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 Tyvaso® approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Tyvaso® in United States?

Insmed Incorporated is the originator. The local marketing authorisation holder may differ — check the official source linked above.