The Japan Ministry of Health, Labor and Welfare (MHLW) has approved Schering-Plough Corporation (NYSE: SGP)’s TEMODAL® (temozolomide) Capsules for the treatment of malignant glioma.
TEMODAL, marketed as TEMODAR® in the US, is already approved in 77 countries. This MHLW approval is a result of a priority review of the New Drug Application (J-NDA) submission granted in September of2005 in order to satisfy an unmet medical need in Japanese patients.
"TEMODAL is a valuable treatment that offers hope to people with malignant glioma," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute.
"Japanese patients who are diagnosed with this devastating disease will now have an important new treatment option."
Malignant gliomas are primary brain tumors that develop from glial cells: glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA) are types of high-grade gliomas; GBM being the most common and aggressive form of primary brain tumor.
TEMODAL be soon be available in Japan as 20 mg and 100 mg capsule strengths soon after price determination by the Japanese Ministry of Health, Labor and Welfare.
Read more at Schering-Plough Corp.
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