🇺🇸 Roflumilast Cream 0.3% in United States

FDA authorised Roflumilast Cream 0.3% on 29 July 2022

Marketing authorisation

FDA — authorised 29 July 2022

  • Application: NDA215985
  • Marketing authorisation holder: ARCUTIS
  • Local brand name: ZORYVE
  • Indication: CREAM — TOPICAL
  • Status: approved

Read official source →

Other Respiratory approved in United States

Frequently asked questions

Is Roflumilast Cream 0.3% approved in United States?

Yes. FDA authorised it on 29 July 2022.

Who is the marketing authorisation holder for Roflumilast Cream 0.3% in United States?

ARCUTIS holds the US marketing authorisation.