FDA — authorised 10 July 2020
- Application: NDA211675
- Marketing authorisation holder: ABBVIE
- Indication: Labeling
- Status: approved
🇺🇸 Rinvoq in United States
FDA authorised Rinvoq on 10 July 2020 · 29,877 US adverse-event reports
Marketing authorisations
FDA — authorised 26 April 2024
- Application: NDA218347
- Marketing authorisation holder: ABBVIE
- Local brand name: RINVOQ LQ
- Indication: SOLUTION — ORAL
- Status: approved
The FDA approved Rinvoq, a medication developed by ABBVIE, on 2025-03-26. The approval was granted through a standard expedited pathway under the application number NDA218347. Rinvoq is indicated for its approved labeling, but the specific indication is not reported in the available data.
FDA
- Application: ANDA218792
- Marketing authorisation holder: SANDOZ INC
- Local brand name: UPADACITINIB
- Indication: TABLET, EXTENDED RELEASE
- Status: approved
FDA
- Application: ANDA218866
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: UPADACITINIB
- Indication: TABLET — ORAL
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 29,877
Most-reported reactions
- Pain — 4,843 reports (16.21%)
- Arthralgia — 4,226 reports (14.14%)
- Drug Ineffective — 3,782 reports (12.66%)
- Covid-19 — 3,037 reports (10.17%)
- Rheumatoid Arthritis — 2,953 reports (9.88%)
- Pain In Extremity — 2,511 reports (8.4%)
- Fatigue — 2,341 reports (7.84%)
- Fall — 2,229 reports (7.46%)
- Surgery — 2,174 reports (7.28%)
- Therapy Interrupted — 1,781 reports (5.96%)
Pricing & reimbursement
- annual_list: USD 84000.00 per year
Rinvoq 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 Rinvoq approved in United States?
Yes. FDA authorised it on 10 July 2020; FDA authorised it on 26 April 2024; FDA has authorised it.
Who is the marketing authorisation holder for Rinvoq in United States?
ABBVIE holds the US marketing authorisation.
What does Rinvoq cost in United States?
annual_list: USD 84000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.