Temodar FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 15, 2023.
FDA Approved: Yes (First approved August 11, 1999)
Brand name: Temodar
Generic name: temozolomide
Company: Merck
Treatment for: Glioblastoma Multiforme, Anaplastic Astrocytoma
Temodar (temozolomide) is an imidazotetrazine derivative for the treatment of anaplastic astrocytoma and glioblastoma multiforme.
- Temodar is indicated for:
- treatment of adults newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
- adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.
- treatment of adults with refractory anaplastic astrocytoma.
Development timeline for Temodar
| Date | Article |
|---|---|
| Sep 14, 2023 | Approval FDA Approves New and Updated Indications for Temozolomide Under Project Renewal |
| Mar 5, 2009 | Approval United States Food and Drug Administration (FDA) Approves IV Formulation of Temodar (temozolomide) |
Further information
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