Treats acute nonlymphocytic leukemias. NDA 12429, held by Waylis Therap. Thioguanine.
As of Nov 14, 2026, NDA 12429 (Thioguanine), held by Waylis Therap, was first approved by FDA on Jan 18, 1966, with 17 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE a) Acute Nonlymphocytic Leukemias TABLOID brand Thioguanine is indicated for remission induction and remission consolidation treatment of acute nonlymphocytic leukemias. However, it is not recommended for use during maintenance therapy or similar long-term continuous treatments due to the high risk of liver toxicity (see WARNINGS and ADVERSE REACTIONS). The response to this agent depends upon the age of the patient (younger patients faring better than older) and whether thioguanine is used in previously treated or previously untreated patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 1966 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thioguanine40MG · tablet;oral | Thioguanine | RxReference drug |
| Jul 9, 2024 | Supplement 29Labeling · Standard review | Approved | |
| May 23, 2018 | Supplement 28Labeling · Standard review | Approved | |
| Nov 15, 2004 | Supplement 22Labeling · Standard review | Approved | |
| Dec 19, 2003 | Supplement 21Labeling · Standard review | Approved | |
| Jun 30, 2003 | Supplement 19Labeling · Standard review | Approved | |
| Jul 3, 2002 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Dec 12, 2001 | Supplement 17Labeling · Standard review | Approved | |
| Jul 15, 1991 | Supplement 15Labeling | Approved | None posted |
| Apr 5, 1990 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Jul 18, 1988 | Supplement 11Manufacturing · Priority review | Approved | None posted |
| Apr 9, 1987 | Supplement 13Labeling | Approved | None posted |
| Sep 22, 1986 | Supplement 12Labeling | Approved | None posted |
| Nov 20, 1985 | Supplement 10Labeling | Approved | None posted |
| Aug 6, 1985 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Mar 13, 1984 | Supplement 8Labeling | Approved | None posted |
| Aug 24, 1978 | Supplement 7Labeling | Approved | None posted |
| Feb 11, 1977 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Jan 18, 1966 | 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
