carmustine

FDA Drug Profile — Gliadel, carmustine, Carmustine

Drug Details

Generic Name
carmustine
Brand Names
Gliadel, carmustine, Carmustine
Application Number
NDA020637
Sponsor
Azurity Pharmaceuticals, Inc.
NDC Codes
7
Dosage Forms
WAFER, KIT
Routes
INTRACAVITARY, INTRAVENOUS
Active Ingredients
CARMUSTINE

Indications and Usage

1 INDICATIONS AND USAGE Carmustine for injection is indicated as palliative therapy as a single agent or in established combination therapy in the following: - Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. - Multiple myeloma in combination with prednisone. - Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs. - Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs. Carmustine for injection is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: • Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) • Multiple myeloma-in combination with prednisone ( 1 ) • Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) • Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 )