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Related tags: abbott, abt, as, autoimmune diseases, drug marketing, drug regulations and approval, emea, eu, humira, jia

  1. Abbott Seeks Approval of First Pediatric Indication for Humira®

    PharmaGazette - Jul 10, 2007

    Abbott (NYSE: ABT) has simultaneously submitted regulatory applications for its drug product HUMIRA® (adalimumab): a supplemental Biologics License Application (sBLA) with the USFDA seeking approval to market HUMIRA® …

    Also tagged: abt, eu, abbott, drug regulations and approval, emea, as, humira, jia, jra

  2. Abbott Seeks Approval of First Pediatric Indication for Humira® [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - May 8, 2007

    Abbott (NYSE: ABT) has simultaneously submitted regulatory applications for its drug product HUMIRA® (adalimumab): a supplemental Biologics License Application (sBLA) with the USFDA seeking approval to market HUMIRA® …

    Also tagged: eu, abbott, drug regulations and approval, emea, as, humira

  3. Abbott Submitted E.U. and U.S. Regulatory Application for HUMIRA® (Adalimumab) as Psoriasis Treatment [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Apr 5, 2007

    Abbott (NYSE: ABT) has submitted a supplemental Biologics License Application (sBLA) to the USFDA and a Type II Variation to the EMEA, seeking marketing approval of HUMIRA® (adalimumab) as a treatment for moderate to …

    Also tagged: abbott, autoimmune diseases, drug marketing, drug regulations and approval, as

  4. REMICADE® Recommended for Approval by EU CHMP for Biologic Treatment of Pediatric Crohn's Disease [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Mar 29, 2007

    Co-developed by Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP), REMICADE® (infliximab) was first approved in the U.S. ( by the USFDA) in 1998 as treatment U.S. for adult Crohn's disease (CD) and later, in …

    Also tagged: cd, uc, drug regulations and approval, emea, chmp, as, schering plough corporation

  5. Abbott’s HUMIRA® (Adalimumab), USFDA-Approved for Crohn's Disease Treatment [PharmaGazette]

    Know More Media - Health Care / Pharmaceutical / Fitness - Feb 28, 2007

    The USFDA granted marketing approval to Abbott (NYSE: ABT) for HUMIRA® (adalimumab) with the following new indications: treatment for reducing the signs and symptoms and inducing and maintaining clinical remission in …

    Also tagged: abbott, gi, antibodies, drug regulations and approval, crohn s