FDAnews
www.fdanews.com/articles/61378-japan-approves-schering-plough-s-temodal

JAPAN APPROVES SCHERING-PLOUGH'S TEMODAL

August 2, 2006

Schering-Plough Corporation has announced that the Japan Ministry of Health, Labor and Welfare (MHLW) has approved TEMODAL (temozolomide) Capsules for the treatment of malignant glioma. The approval of TEMODAL by the MHLW follows a priority review of the New Drug Application (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 US, is approved in 77 countries.

BioSpectrum (http://www.biospectrumasia.com/content/010806JPN1251.asp)