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See Latest ArticlesFDA Issues Complete Response Letter for INTUNIV (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
Shire, 07/29/09
Shire plc , the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV TM Extended Release from the Food and Drug Administration. This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.
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