🇺🇸 Rezurock in United States

FDA authorised Rezurock on 16 July 2021

Marketing authorisation

FDA — authorised 16 July 2021

  • Application: NDA214783
  • Marketing authorisation holder: KADMON PHARMS LLC
  • Local brand name: REZUROCK
  • Indication: TABLET — ORAL
  • Status: approved

The FDA granted marketing authorisation to KADMON PHARMS LLC for Rezurock. The approval was based on a standard application pathway. The exact indication approved for Rezurock is listed in its labelling.

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Rezurock in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Rezurock approved in United States?

Yes. FDA authorised it on 16 July 2021.

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

KADMON PHARMS LLC holds the US marketing authorisation.