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

knowmoremedia.com » 2007 » May » 8th » Abbott Seeks Approval of First Pediatric Indication for Humira® [PharmaGazette]

Tagged: eu, abbott, drug regulations and approval, emea, ra, as, humira

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® (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S. a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® … Continue Reading »

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