NDA 213400, held by Epizyme Inc. Tazemetostat Hydrobromide.
As of Nov 13, 2026, NDA 213400 (Tazverik), held by Epizyme Inc, was first approved by FDA on Jun 18, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 2020 | Original applicationNew indication · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tazverik200MG · tablet;oral | Tazemetostat Hydrobromide | Rx |
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
