Press Release
Shire Receives Approvable Letter from FDA for INTUNIV™ (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
June 21, 2007
Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike some other ADHD treatments, INTUNIV, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency’s request.
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