Treats moderately to severely active rheumatoid arthritis. NDA 211675, held by Abbvie. Upadacitinib.
As of Nov 13, 2026, NDA 211675 (Rinvoq), held by Abbvie, was first approved by FDA on Aug 16, 2019, with 19 approved supplements and 0 published complete response letters.
RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine. RINVOQ/RINVOQ LQ is indicated for the treatment of adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Limitation s of Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 10, 2025 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Apr 28, 2025 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2024 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2024 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Jun 22, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Oct 21, 2022 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2022 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2021 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 16, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rinvoq15MG · tablet, extended release;oral | Upadacitinib | RxReference drug |
| Rinvoq30MG · tablet, extended release;oral | Upadacitinib | RxReference drug |
| Rinvoq45MG · tablet, extended release;oral | Upadacitinib | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2026 | Supplement 34Labeling · Standard review | Approved | |
| Oct 10, 2025 | Supplement 28Efficacy (new indication or use) · Standard review | Approved | |
| Aug 12, 2025 | Supplement 29Manufacturing | Approved | |
| Apr 28, 2025 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Mar 26, 2025 | Supplement 27Labeling · Standard review | Approved | |
| Apr 26, 2024 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Apr 26, 2024 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Nov 14, 2023 | Supplement 19Labeling · Standard review | Approved | |
| Jun 22, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| May 18, 2023 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Apr 10, 2023 | Supplement 12Labeling · Standard review | Approved | |
| Oct 21, 2022 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 29, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 2022 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jan 14, 2022 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Dec 14, 2021 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 14, 2021 | Supplement 5Labeling · Standard review | Approved | |
| Dec 2, 2021 | Supplement 8Labeling · Standard review | Approved | |
| Jul 10, 2020 | Supplement 1Labeling · Standard review | Approved | |
| Aug 16, 2019 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
