NDA 217865, held by Italfarmaco Spa. Givinostat Hydrochloride.
As of Nov 13, 2026, NDA 217865 (Duvyzat), held by Italfarmaco Spa, was first approved by FDA on Mar 21, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 21, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| DuvyzatEQ 8.86MG BASE/ML · suspension;oral | Givinostat Hydrochloride | RxReference drug |
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
