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INTUNIV in Medical News

Shire's INTUNIV (Guanfacine) extended release in children with ADHD and oppositional symptoms

San Francisco, CA May 18, 2009 Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced new findings on INTUNIV (guanfacine) extended release, a selective alpha-2A-agonist, at a major psychiatric meeting. This randomized placebo controlled trial met i...

Shire investigational nonstimulant INTUNIV showed significant efficacy in reducing ADHD symptoms

WASHINGTON, May 7 -- Shire plc(LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, presented today at a major scientific meeting findings from analyses of pivotal trial results of INTUNIV, a selective alpha-2A-agonist. This compound is an investigational once-daily medic...

FDA Approves INTUNIV (guanfacine) for the Treatment of ADHD

Shire announced today that it has received an approvable letter from the US 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 adolescent...
INTUNIV in Medical Technology

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

...The FDA did not identify safety concerns regarding intuniv in the Complete Response letter or request new cli...h an important new treatment option." About intuniv intuniv is being studied for the treatment of ADHD in chil...

Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms

...aceutical company, today announced new findings on intuniv (guanfacine) extended release, a selective alpha-2...ry objective, which was to evaluate the effects of intuniv on oppositional symptoms in children aged 6 to 12 ...de additional support for the clinical efficacy of intuniv for treating ADHD in this patient population." ...

Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose

...tivity Disorder (ADHD). The data demonstrated that intuniv showed significant efficacy in reducing ADHD sympt...s for all weight adjusted dose groups treated with intuniv when compared to placebo for all time periods (at ...m the analysis showed that all groups treated with intuniv responded to the medication in a shorter time peri...
INTUNIV in Biological Technology

Shire plc: Core Portfolio of Products Delivers 20% Sales Growth

... Prescription Drug User Fee Act date ("PDUFA") for intuniv was July 27, 2009. Shire has received a Comp...rican countries during 2009 and 2010; - intuniv for the treatment of ADHD in children and adolesce... 158.7 28% 136.4 19% intuniv license payment (36.9) - ...

Shire begins the year with a strong performance

...half of the year we are anticipating the launch of intuniv and the completion of several Phase 2 and Phase 3 ... The Prescription Drug User Fee Act date for intuniv is July 26, 2009 and the launch of intuniv in the US is anticipated for the fourth quar...

Publication of Shire plc's Annual Report 2008

...r 2007 and in the EU via the decentralized procedure, with the Netherlands as the reference member state in December 2007. Reviews are ongoing. intuniv for ADHD in US In June 2007 Shire received an approvable letter from the FDA for INTUNIV. Shire is conducting additional clinical work which is...

Shire Delivers Excellent Growth for the Year, With the new Product Portfolio Achieving Sales of $1 Billion

...- FIRAZYR (icatibant) for the symptomatic treatment of acute attacks of HAE in certain European and Latin American countries during 2009; - intuniv (guanfacine extended release) for use in the treatment of ADHD in children and adolescents in the US in the second half of 2009; - FO...

Shire Delivers Strong Quarter: Driven by $243m of New Product Sales (+164% YOY Growth). Revenue Guidance Upgrade.

...NIV(TM) - ADHD - On May 8, 2008 Shire announced pivotal trial results for intuniv which is in registration in the US. The data demonstrated that intuniv has significant efficacy in reducing ADHD symptoms for patients taking t...

Following a Good Start to the Year Shire Reaffirms Full Year 2008 Financial Guidance

...two years: - MEZAVANT in the EU during 2008; - VYVANSE for use in adult patients in the US in Q2 2008; - DAYTRANA in the EU during H1 2009; - intuniv in the US during H2 2009; and - FOSRENOL in the pre-dialysis Chronic Kidney Disease ("CKD") market in the US during 2009. 2008 Financial Outlook ...

Shire plc: Excellent Performance Across All Areas of the Business and Accelerating New Product Sales Drive Revenue Growth of 36%

...ada during 2008; - VYVANSE for use in adult patients in the US in Q2 2008 (PDUFA date April 28, 2008); - DAYTRANA in the EU during H1 2009; - intuniv in the US during H2 2009; and - FOSRENOL in the CKD market in the US during 2009. Financial Outlook Shire's business continues to perform strongl...
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