an inadequate response to conventional therapy. REMICADE was first approved in the U.S. for adult Crohn's disease in 1998 and later for adult ulcerative colitis in 2005.

The safety and efficacy of REMICADE across all indications have been well established in clinical trials over the past 14 years and through commercial experience with nearly 925,000 patients treated worldwide across all indications.

The label extension will permit physicians to administer a 5 mg/kg intravenous infusion of REMICADE over a 2-hour period followed by additional 5 mg/kg infusion doses at two and six weeks after the first infusion, then every eight weeks thereafter.

Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. Available data do not support further REMICADE treatment in pediatric patients not responding within the first 10 weeks of treatment.


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