Treats active rheumatoid arthritis (RA). NDA 20905, held by Sanofi Aventis US. Leflunomide.
As of Nov 14, 2026, NDA 20905 (Arava), held by Sanofi Aventis US, was first approved by FDA on Sep 10, 1998, with 20 approved supplements and 0 published complete response letters.
ARAVA is indicated for the treatment of adults with active rheumatoid arthritis (RA).
| Mar 5, 2004 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2003 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Sep 10, 1998 | Original applicationNew molecular entity · Priority review | Approved |
| Arava10MG · tablet;oral | Leflunomide | RxReference drug |
| Arava20MG · tablet;oral | Leflunomide | RxReference drug |
| Arava100MG · tablet;oral | Leflunomide | DiscontinuedReference drug |
| Jun 28, 2024 | Supplement 33Labeling · Standard review | Approved | |
| Oct 18, 2016 | Supplement 31Labeling · Standard review | Approved | |
| Aug 28, 2015 | Supplement 27Labeling · Standard review | Approved | |
| Apr 29, 2015 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Nov 14, 2014 | Supplement 28Labeling · Standard review | Approved | |
| Nov 2, 2012 | Supplement 25Labeling · Standard review | Approved | |
| Jul 8, 2011 | Supplement 22Labeling · Standard review | Approved | |
| Sep 9, 2010 | Supplement 20Labeling | Approved | |
| Apr 3, 2009 | Supplement 18Labeling · Standard review | Approved | |
| Nov 8, 2007 | Supplement 16Labeling · Standard review | Approved | |
| Oct 19, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Nov 22, 2004 | Supplement 14Labeling · Standard review | Approved | |
| Mar 5, 2004 | Supplement 12Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2003 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jun 13, 2003 | Supplement 7Labeling · Standard review | Approved | |
| Sep 21, 2000 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Feb 23, 2000 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 23, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 20, 1999 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 11, 1998 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 10, 1998 | 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
