FDA — authorised 21 September 2021
- Application: NDA215309
- Marketing authorisation holder: INCYTE CORP
- Local brand name: OPZELURA
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 Ruxolitinib Cream in United States
FDA authorised Ruxolitinib Cream on 21 September 2021
Marketing authorisations
FDA
- Status: approved
Ruxolitinib Cream 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 Ruxolitinib Cream approved in United States?
Yes. FDA authorised it on 21 September 2021; FDA has authorised it.
Who is the marketing authorisation holder for Ruxolitinib Cream in United States?
INCYTE CORP holds the US marketing authorisation.