temozolomide
Drug Details
- Generic Name
- temozolomide
- Brand Names
- temozolomide, TEMOZOLOMIDE
- Application Number
- ANDA213328
- Sponsor
- Nivagen Pharmaceuticals, Inc.
- NDC Codes
- 14
- Dosage Forms
- CAPSULE, POWDER, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- ORAL
- Active Ingredients
- TEMOZOLOMIDE
Indications and Usage
1. INDICATIONS AND USAGE TEMOZOLOMIDE Capsules, USP are an alkylating drug indicated for the treatment of adult patients with: • Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1 ) • Refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. ( 1.2 ) 1.1 Newly Diagnosed Glioblastoma TEMOZOLOMIDE Capsules, USP is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. 1.2 Refractory Anaplastic Astrocytoma TEMOZOLOMIDE Capsules , USP is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.