Schering-Plough Corporation
CHMP Recommends Approval in the European Union (EU) for New Options for Patients With Certain Primary Brain Tumors
Published in Medical Letter on the CDC and FDA, December 28th, 2008
Schering-Plough Corporation (NYSE:SGP) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion recommending approval of the intravenous (IV) formulation of TEMODAL(R) (temozolomide) as an alternative to the already approved oral form of temozolomide in the EU. The CHMP also has issued a positive opinion recommending approval of a sachet packaging presentation for TEMODAL Capsules. This new presentation was created to provide greater patient convenience and flexibility.
TEMODAL Capsules are a chemotherapy agent approved in the EU for treatment of patients with newly diagnosed...
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