🇺🇸 Ambrisentan Pill in United States

FDA authorised Ambrisentan Pill on 15 June 2007

Marketing authorisations

FDA — authorised 15 June 2007

  • Application: NDA022081
  • Marketing authorisation holder: GILEAD
  • Local brand name: LETAIRIS
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

Ambrisentan Pill 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 Ambrisentan Pill approved in United States?

Yes. FDA authorised it on 15 June 2007; FDA has authorised it.

Who is the marketing authorisation holder for Ambrisentan Pill in United States?

GILEAD holds the US marketing authorisation.