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www.fdanews.com/articles/87702-gsk-gets-japanese-approval-for-crohn-s-disease-drug

GSK GETS JAPANESE APPROVAL FOR CROHN'S DISEASE DRUG

June 20, 2006

GlaxoSmithKline (GSK) has received additional approval for Imuran tablets, its proprietary immunosuppressant, from the Japanese Ministry of Health, Labor and Welfare.

Imuran is now approved for the treatment of steroid-dependent Crohn's disease and steroid-dependent ulcerative colitis in the remission period.

Currently available in over 100 countries worldwide, Imuran is indicated for the treatment of rejection in organ transplants. In addition, the agent is indicated for the treatment of inflammatory bowel disease in 15 countries including France and Germany.

GlaxoSmithKline and UCB Japan are co-promoting Imuran in Japan, the company said.