🇺🇸 Extended-release sodium oxybate in United States

FDA authorised Extended-release sodium oxybate on 1 May 2023

Marketing authorisations

FDA — authorised 1 May 2023

  • Application: NDA214755
  • Marketing authorisation holder: AVADEL CNS
  • Local brand name: LUMRYZ
  • Indication: FOR SUSPENSION, EXTENDED RELEASE — ORAL
  • Status: approved

Read official source →

FDA

  • Status: approved

Extended-release sodium oxybate 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 Extended-release sodium oxybate approved in United States?

Yes. FDA authorised it on 1 May 2023; FDA has authorised it.

Who is the marketing authorisation holder for Extended-release sodium oxybate in United States?

AVADEL CNS holds the US marketing authorisation.