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Japan’s MHLW Approves S-P’s Brain Cancer Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Schering-Plough received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Temodal capsules for the treatment of malignant glioma. The approval follows a priority review of the J-NDA submission, which was granted in September of 2005 in order to satisfy an unmet medical need in Japanese patients. Temodal, marketed as Temodar in the U.S., is approved in 77 countries. Temodal will become available once pricing is determined by the Japanese MHLW. Malignant gliomas are prima...

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