🇺🇸 DOR in United States

FDA authorised DOR on 20 April 2026

Marketing authorisation

FDA — authorised 20 April 2026

  • Application: NDA216964
  • Marketing authorisation holder: MSD
  • Local brand name: IDVYNSO
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved MSD's New Drug Application (NDA216964) for IDVYNSO (DOR), an oral tablet, on 20 April 2026. This approval was granted under the standard expedited pathway. IDVYNSO is indicated for [insert indication, as it is not specified in the provided information].

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Frequently asked questions

Is DOR approved in United States?

Yes. FDA authorised it on 20 April 2026.

Who is the marketing authorisation holder for DOR in United States?

MSD holds the US marketing authorisation.