Treats acute iron intoxication. NDA 16267, held by Mitem Pharma. Deferoxamine Mesylate.
As of Nov 13, 2026, NDA 16267 (Desferal), held by Mitem Pharma, was first approved by FDA on Apr 1, 1968, with 40 approved supplements and 0 published complete response letters.
DESFERAL is an iron-chelating agent indicated: As an adjunct to standard measures for the treatment of acute iron intoxication. For the treatment of transfusional iron overload in patients with chronic anemia. Limitations of Use Desferal is not indicated for the treatment of primary hemochromatosis (since phlebotomy is the method of choice for removing excess iron in this disorder). 1.1 Acute Iron Intoxication DESFERAL is indicated as an adjunct to standard measures for the treatment of acute iron intoxication. 1.2 Chronic Iron Overload DESFERAL is indicated for the treatment of transfusional iron overload in patients with chronic anemia. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 4, 1979 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Apr 1, 1968 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Desferal500MG/VIAL · injectable;injection | Deferoxamine Mesylate | RxReference drug |
| Desferal2GM/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Deferoxamine Mesylate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2022 | Supplement 62Labeling · Standard review | Approved | |
| Apr 27, 2016 | Supplement 52Manufacturing · Priority review | Approved | None posted |
| Jun 14, 2013 | Supplement 51Manufacturing · Priority review | Approved | None posted |
| Dec 16, 2011 | Supplement 50Labeling · Standard review | Approved | |
| Sep 7, 2010 | Supplement 47Labeling | Approved | |
| Jan 28, 2009 | Supplement 45Labeling · Standard review | Approved | |
| Jan 19, 2007 | Supplement 44Labeling · Standard review | Approved | |
| Apr 24, 2002 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Feb 14, 2002 | Supplement 39Labeling · Standard review | Approved | |
| Jan 15, 2002 | Supplement 40Manufacturing · Priority review | Approved | None posted |
| Jul 5, 2001 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Apr 9, 2001 | Supplement 34Labeling · Standard review | Approved | |
| Jan 5, 2001 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| May 25, 2000 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Apr 28, 2000 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Dec 22, 1998 | Supplement 31Manufacturing · Priority review | Approved | None posted |
| Dec 22, 1998 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Dec 22, 1998 | Supplement 29Manufacturing · Priority review | Approved | None posted |
| Oct 23, 1998 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Jan 30, 1998 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jan 30, 1998 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Apr 2, 1997 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jun 19, 1995 | Supplement 27Labeling · Standard review | Approved | None posted |
| Aug 31, 1994 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 12, 1990 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Sep 8, 1987 | Supplement 21Labeling | Approved | None posted |
| Feb 13, 1987 | Supplement 20Labeling | Approved | None posted |
| Apr 17, 1986 | Supplement 15Labeling | Approved | None posted |
| Jan 8, 1986 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Sep 27, 1985 | Supplement 19Manufacturing · Priority review | Approved | None posted |
| Apr 6, 1984 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Jan 4, 1984 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Sep 2, 1980 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 8, 1980 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jun 4, 1979 | Supplement 12Labeling | Approved | None posted |
| Jun 4, 1979 | Supplement 11Efficacy (new indication or use) | Approved | None posted |
| Apr 6, 1978 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Jan 25, 1978 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Mar 4, 1977 | Supplement 8REMS · Priority review | Approved | None posted |
| Jan 20, 1976 | Supplement 7Labeling | Approved | None posted |
| Apr 1, 1968 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
