Temodar gets UK/US appro in IV form

16 March 2009

US drug major Schering-Plough has received approval for an intravenous formulation of Temodar/Temodal (temozolomide) from both the Food and  Drug Administration and the European Commission.

Temodal is a chemotherapy agent approved in the European Union for the  treatment of patients with newly-diagnosed glioblastoma multiforme  concomitantly with radiotherapy and subsequently as monotherapy, and  for patients with malignant gliomas, such as GBM or anaplastic  astrocytoma, showing recurrence or progression after standard therapy.  In the USA, where the agent is known as Temodar, it is approved for the  treatment of adult patients with newly-diagnosed GBM concomitantly with  radiotherapy and then as maintenance treatment, as well as for  refractory AA.

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