ROCKVILLE, Md. The Food and Drug Administration has granted Schering-Plough a new drug approval.
The FDA’s Office of Oncology Drug Products approved injectable Temodar (temozolomide) last week for the treatment of adult patients with newly diagnosed with glioblastoma multiforme concomitantly with radiotherapy and as a maintenance treatment and for treating adult patients with refractory anaplastic astrocytoma. Both are tumors of the brain.
The FDA approved Temodar capsules in 1999 as a treatment for brain tumors, according to the agency’s drug database. The injected drug will be available in 100 mg vials.