🇺🇸 Macitentan and Tadalafil in United States

FDA authorised Macitentan and Tadalafil on 2 April 2025

Marketing authorisation

FDA — authorised 2 April 2025

  • Application: NDA218490
  • Marketing authorisation holder: ACTELION
  • Indication: REMS
  • Status: approved

The FDA granted marketing authorization to ACTELION for Macitentan and Tadalafil on April 2, 2025. This approval was made under the standard expedited pathway for NDA218490. The approved indication is subject to a Risk Evaluation and Mitigation Strategy (REMS).

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Macitentan and Tadalafil 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 Macitentan and Tadalafil approved in United States?

Yes. FDA authorised it on 2 April 2025.

Who is the marketing authorisation holder for Macitentan and Tadalafil in United States?

ACTELION holds the US marketing authorisation.