Treats newly diagnosed acute myeloid leukemia (AML). NDA 216993, held by Daiichi Sankyo Inc. Quizartinib Dihydrochloride.
As of Nov 13, 2026, NDA 216993 (Vanflyta), held by Daiichi Sankyo Inc, was first approved by FDA on Jul 20, 2023, with 3 approved supplements and 0 published complete response letters.
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 20, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| VanflytaEQ 17.7MG BASE · tablet;oral | Quizartinib Dihydrochloride | RxReference drug |
| VanflytaEQ 26.5MG BASE · tablet;oral | Quizartinib Dihydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2026 | Supplement 3REMS | Approved | |
| Apr 13, 2026 | Supplement 2Labeling · Standard review | Approved | |
| Jun 25, 2024 | Supplement 1Labeling · Standard review | Approved | |
| Jul 20, 2023 | 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
