Treats chronic iron overload due to blood transfusions. NDA 21882, held by Novartis. Deferasirox.
As of Nov 15, 2026, NDA 21882 (Exjade), held by Novartis, was first approved by FDA on Nov 2, 2005, with 24 approved supplements and 0 published complete response letters.
Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.
| Jul 23, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2019 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2019 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Dec 12, 2018 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| May 11, 2018 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Jan 23, 2013 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Nov 2, 2005 | Original applicationNew molecular entity · Priority review | Approved |
| Exjade125MG · tablet, for suspension;oral | Deferasirox | RxReference drug |
| Exjade250MG · tablet, for suspension;oral | Deferasirox | RxReference drug |
| Exjade500MG · tablet, for suspension;oral | Deferasirox | RxReference drug |
| Jan 17, 2023 | Supplement 37Manufacturing | Approved | |
| Jul 23, 2020 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jul 24, 2019 | Supplement 30Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2019 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Dec 12, 2018 | Supplement 29Labeling · Standard review | Approved | |
| Dec 12, 2018 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| May 11, 2018 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Feb 16, 2018 | Supplement 26Labeling · Standard review | Approved | |
| Aug 12, 2016 | Supplement 24Labeling · Standard review | Approved | |
| Jul 23, 2015 | Supplement 21Labeling · Standard review | Approved | |
| Nov 1, 2013 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Oct 21, 2013 | Supplement 19Labeling · Standard review | Approved | |
| May 29, 2013 | Supplement 17Labeling · Standard review | Approved | |
| Jan 23, 2013 | Supplement 16Labeling · Standard review | Approved | |
| Jan 23, 2013 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2012 | Supplement 14Labeling · Standard review | Approved | |
| Aug 10, 2011 | Supplement 12Labeling · Standard review | Approved | |
| Apr 11, 2011 | Supplement 11Labeling · Standard review | Approved | |
| Jan 28, 2010 | Supplement 10Labeling | Approved | |
| Apr 22, 2009 | Supplement 6Labeling · Standard review | Approved | |
| Mar 5, 2009 | Supplement 7Labeling · Standard review | Approved | |
| Oct 2, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Dec 21, 2007 | Supplement 3Labeling · Standard review | Approved | |
| Apr 20, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Nov 2, 2005 | 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
