http://www.rxpgnews.com/ Medical News and Information Thu, 21 Aug 2008 02:00:28 PST en-us http://www.rxpgnews.com/infliximab/FDA_grants_priority_review_of_infliximab_for_child_3910_3910.shtml Infliximab Centocor, Inc. announced today that the supplemental Biologics License Application (sBLA) for REMICADE (R) (infliximab) for the treatment of pediatric Crohn's disease has been accepted and designated for Priority Review by the U.S. Food and Drug Administration (FDA). Centocor is seeking approval for the treatment of moderately to severely active pediatric Crohn's disease in patients who have had an inadequate response to conventional therapies. Currently, there are no approved biologic therapies for the treatment of pediatric Crohn's disease, a chronic, potentially debilitating condition that causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhea, fever, abdominal pain and weight loss. Children with Crohn's disease may also experience delayed development and stunted growth. Orphan drug designation was granted by the FDA to REMICADE for the treatment of pediatric Crohn's disease on November 12, 2003. In addition, on August 30, 2004 a REMICADE Phase 3 clinical development program for pediatric Crohn's disease was designated Fast Track by the FDA. Wed, 05 Apr 2006 14:06:00 PST http://www.rxpgnews.com/infliximab/FDA_grants_priority_review_of_infliximab_for_child_3910_3910.shtml http://www.rxpgnews.com/infliximab/CHMP_approves_Infliximab_for_the_treatment_of_mode_1984_1984.shtml Infliximab Centocor BV and Schering-Plough Corporation announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending the approval of an expanded indication for REMICADE (infliximab). Mon, 01 Aug 2005 23:20:00 PST http://www.rxpgnews.com/infliximab/CHMP_approves_Infliximab_for_the_treatment_of_mode_1984_1984.shtml