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Article: FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents.
- Article from:
- PR Newswire Europe
- Article date:
- July 28, 2009
CopyrightCOPYRIGHT 2009 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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PHILADELPHIA, July 28 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter today for INTUNIV(TM) (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.
The FDA did not identify safety concerns regarding INTUNIV in the Complete Response letter or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labeling language over the next 4 to 8 weeks.
"Shire ...