NDA 212576, held by Taiho Oncology. Cedazuridine; Decitabine.
As of Nov 13, 2026, NDA 212576 (Inqovi), held by Taiho Oncology, was first approved by FDA on Jul 7, 2020, with 2 approved supplements and 0 published complete response letters.
INQOVI is a combination of decitabine, a nucleoside metabolic inhibitor, and cedazuridine, a cytidine deaminase inhibitor, indicated: For treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia [CMML]) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.
| May 13, 2026 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jul 7, 2020 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Inqovi100MG;35MG · tablet;oral | Cedazuridine; Decitabine | RxReference drug |
| May 13, 2026 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Jul 7, 2020 | Original applicationNew molecular entity, new combination · 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
