When did the FDA approve upadacitinib for Crohn’s disease?
Upadacitinib (brand name: Rinvoq) received FDA approval for the Crohn’s disease indication on May 16, 2022. [1]
What’s the timeline for Rinvoq’s Crohn’s indication expansion?
The FDA approval date above corresponds to the initial Crohn’s disease indication approval for upadacitinib. If you’re tracking later label expansions (for example, additional patient populations or disease severities), those would have separate FDA approval dates beyond May 16, 2022. [1]
Why might people see different dates online?
Different sources may show:
- the FDA approval date for the overall indication (May 16, 2022), versus
- the dates for related documents such as press releases, label updates, or supplemental approvals tied to narrower subgroups.
For the approval date itself, the most direct reference is the FDA approval listing for Rinvoq’s Crohn’s disease indication. [1]
Patent/exclusivity check (if you’re researching timing)
If you’re researching exclusivity or patent status for upadacitinib around the Crohn’s indication, DrugPatentWatch.com is a commonly used reference point for tracking related patent timelines. [2]
Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206914
[2] https://www.drugpatentwatch.com/