NDA 22277, held by Merck Sharp Dohme. Temozolomide.
As of Nov 14, 2026, NDA 22277 (Temodar), held by Merck Sharp Dohme, was first approved by FDA on Feb 27, 2009, with 14 approved supplements and 0 published complete response letters.
TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Anaplastic astrocytoma. Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. Treatment of adults with refractory anaplastic astrocytoma. 1.1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.
| Sep 14, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Feb 27, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Temodar100MG/VIAL · powder;intravenous | Temozolomide | RxReference drug |
| Sep 14, 2023 | Supplement 17Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Nov 22, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Oct 6, 2017 | Supplement 12Labeling · Standard review | Approved | |
| Feb 24, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Feb 12, 2016 | Supplement 11Labeling · Standard review | Approved | |
| Sep 18, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Apr 2, 2015 | Supplement 8Labeling · Standard review | Approved | |
| May 5, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Jun 3, 2011 | Supplement 5Labeling | Approved | |
| Feb 4, 2011 | Supplement 4Labeling | Approved | |
| Apr 26, 2010 | Supplement 1Labeling · Standard review | Approved | |
| Feb 27, 2009 | Original applicationNew dosage form · Standard 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
