🇺🇸 Remifentanil infusion in United States

FDA authorised Remifentanil infusion on 28 June 2024

Marketing authorisations

FDA — authorised 28 June 2024

  • Application: ANDA215635
  • Marketing authorisation holder: NIVAGEN PHARMS INC
  • Local brand name: REMIFENTANIL HYDROCHLORIDE
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA

  • Status: approved

Remifentanil infusion 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 Remifentanil infusion approved in United States?

Yes. FDA authorised it on 28 June 2024; FDA has authorised it.

Who is the marketing authorisation holder for Remifentanil infusion in United States?

NIVAGEN PHARMS INC holds the US marketing authorisation.