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FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
Date:7/28/2009

R. Alpha-2 adrenergic receptor agonists for the treatment of attention-deficit/hyperactivity disorder: emerging concepts from new data.

J of Child and Adolesc Psychopharmacology. 2007;17:4:393-406.

5. MacDonald E, Kobilka BK, Scheinin M. Gene targeting-homing in on alpha-2-adrenoceptor subtype function. Trends in Pharmacol Sci. 1997;18:211-219.

6. Wang M, Arnsten AF, Brennan A, et al. ÿ±2A-adrenoceptors strengthen working memory networks by inhibiting cAMP-HCN channel signaling in prefrontal cortex. Cell. 2007;129:397-410.

7. Arnsten AF, Li BM. Neurobiology of executive functions: catecholamine influences on prefrontal cortical functions. Biol Psychiatry. 2005; 57:1377-1385.

8. Steere JC, Arnsten AFT. The alpha-2A noradrenergic agonist, guanfacine, improves visual object discrimination reversal performance in rhesus monkeys. Behav Neurosci. 1997;111:1-9.

9. Mao Z-M, Arnsten AFT, Li B-M. Local infusion of alpha-1 adrenergic agonist into the prefrontal cortex impairs spatial working memory performance in monkeys. Biol Psychiatry. 1999;46:1259-1265.

10. Jakala P, Riekkinen M, Sirvio, J, et al. Guanfacine, but not clonidine, improves planning and working memory performance in humans. Neuropsychopharmacology. 1999;2[5]:460-470.

11. INTUNIV Data on File SPD503005; Shire plc. ISS Summary of Clinical Safety 2006; -: 1-190.

12. Pliszka S and the AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.

13. Polanczyk G, de Lima MS, Horta BL, et al. The worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psych. 2007; 164:942-948.

14. Mental health in the United States: Prevalence of diagnosis and medication treat
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