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FDA Approves INTUNIV® (guanfacine) Extended-Release Tablets for Use as Adjunctive Therapy to Stimulants for the Treatment of ADHD in Children and Adolescents
Date:2/28/2011

for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

References:

  1. INTUNIV [package insert], Wayne, PA: Shire US Inc.; 02/2011.
  2. Wilens T, Bukstein OG, Cutler AJ, Findling RL, Youcha S, White C, Rubin J. A multicenter placebo controlled study of extended-release guanfacine coadministered with stimulants in the treatment of ADHD: Effects on overall, morning, and evening ADHD assessments. Paper presented at: American Academy of Child and Adolescent Psychiatry Annual Meeting; October 28, 2010; New York, NY.
  3. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed., Text Revision (DSM-IV-TR ®). Washington, DC: American Psychiatric Association; 2000:85-93.
  4. 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.
  5. Centers for Disease Control and Prevention. Increasing prevalence of parent reported attention deficit/hyperactivity disorder among children -- United States, 2004 and 2007. Morb Mortal Weekly Rep (MMWR). 2010;59(44):1439-1443.


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