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

PHILADELPHIA, July 28 /PRNewswire-FirstCall/ -- 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 is confident that we will quickly come to agreement on the final product label and anticipates a launch in the fourth quarter as planned," said Mike Cola, President of Shire Specialty Pharmaceuticals. "When approved, INTUNIV will be the first selective alpha-2A receptor agonist for the treatment of ADHD, and will provide patients with an important new treatment option."

About INTUNIV

INTUNIV is being studied for the treatment of ADHD in children and adolescents aged 6 to 17 years. INTUNIV is a once-daily, extended release formulation of guanfacine, designed to provide steady delivery of drug throughout the day. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

Guanfacine, the active ingredient in INTUNIV, is thought to work directly by binding selectively to alpha-2A adrenergic receptors located in the prefrontal cortex - an area of the brain that has been linked to ADHD.(4-6) Stimulation of the postsynaptic alpha-2A receptors is thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition and enhance
'/>"/>

SOURCE Shire Plc
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. The First Annual Cervical Cancer/HPV Conference Tackles Controversial Vaccine Issues and Encourages Advocacy
2. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
3. European CHMP Issues Positive Opinion for ATRIPLA(R) (efavirenz 600 mg/ emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)
4. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
5. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on CEL-SCI Corporation
6. QIAGEN and Center for Molecular Medicine Create Research Collaboration for Molecular Diagnostic Markers for Breast Cancer, Other Womens Health Issues
7. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Bioniche Life Sciences Inc.
8. Lupus Under the Spotlight: U.S. Congress Shows Support for Womens Health Issues
9. European Unions CHMP Issues Positive Opinion on Sugammadex
10. Newly Published Study Shows OPKOs siRNA Bevasiranib Is Taken Up by Target Tissues in the Eye
11. Ending Cervical Cancer Featured at Summit; QIAGEN CEO Issues a Call to Global Women Leaders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/16/2014)... Sept. 16, 2014  Wearable sports and activity ... less than two years, producing a massive amount ... huge opportunity exists for leveraging this data to ... ) introduced a first-of-its-kind wearable analytics platform for ... of clinical research linking activity and health risks, ...
(Date:9/16/2014)... Sept. 16, 2014  Relmada Therapeutics, Inc., (OTCBB: RLMD), ... of chronic pain, announced today that it has entered ... (MSKCC) in a series of animal studies for levorphanol, ... extended release form of levorphanol.  Gavril Pasternak, MD, PhD, ... Dr. Pasternak said, "Levorphanol is a ...
(Date:9/16/2014)... 2014 Henry Schein, Inc. (NASDAQ: ... health care products and services to office-based dental, ... Stanley M. Bergman, Henry Schein,s Chairman of the Board and ... services panel at the Leerink Partners Services Roundtable on Tuesday, ... Dr. Stohler, Dean of Columbia University,s College of ...
Breaking Medicine Technology:Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 2Doctors Launch Initiative to Bridge Gap Between Wearables and Meaningful Health Data 3Relmada Therapeutics Enters Into Agreement with Memorial Sloan Kettering to Better Clarify Unique Mechanism of Action for LevoCap ER 2Relmada Therapeutics Enters Into Agreement with Memorial Sloan Kettering to Better Clarify Unique Mechanism of Action for LevoCap ER 3Henry Schein To Present At The Leerink Partners Services Roundtable 2
(Date:9/16/2014)... September 16, 2014 Recently, BuyTopDress.com, one ... has unveiled its new collection of elegant graduation ... these brand new items are on sale on the ... from 23 to 63 percent off. , These ... and design. They are available in a lot of ...
(Date:9/16/2014)... CA (PRWEB) September 16, 2014 Dr. ... the launch of ACLsurgeryLA.com , a specialty website ... injuries. As an avid sports lover and athlete, ... for treatment and recovery from injuries to maintain active, ... to offer patients a resource dedicated specifically to ...
(Date:9/16/2014)... 2014 MEDICC Review today ... genetics in Cuba. Although the articles do not ... are intrinsically connected, since cancers begin with errors in ... full spectrum of cancer control, from primary prevention to ... topic of an exclusive interview with National Medical ...
(Date:9/16/2014)... (PRWEB) September 16, 2014 Lambda Solutions, a ... systems , is excited to welcome Stewart Rogers ... Harvey, Sales Executive at Lambda Solutions comments, “Product leadership will ... right candidate to do so. Learning and talent management is ... changes to help clinical learning and talent development in the ...
(Date:9/16/2014)... Birmingham, Alabama (PRWEB) September 16, 2014 *To ... Birmingham, AL, visit Achieve Clinical Research on the web ( ... For those who qualify:, There is ... required , Compensation may be provided for ... stands, pneumonia and influenza are the eighth leading cause of ...
Breaking Medicine News(10 mins):Health News:Cheap Graduation Dresses Now Provided Online At BuyTopDress.com 2Health News:Los Angeles Orthopedic Surgeon Spotlights ACL Conditions With New Website 2Health News:Los Angeles Orthopedic Surgeon Spotlights ACL Conditions With New Website 3Health News:MEDICC Review Journal Dedicates Double Issue to Cancer and Genetics 2Health News:MEDICC Review Journal Dedicates Double Issue to Cancer and Genetics 3Health News:Stewart Rogers Joins Lambda Solutions as Director of Product Management 2Health News:Stewart Rogers Joins Lambda Solutions as Director of Product Management 3Health News:The Team at Achieve Clinical Research is Enrolling Qualified Individuals to Participate in a Pneumonia Vaccine Clinical Trial in Birmingham, Alabama 2Health News:The Team at Achieve Clinical Research is Enrolling Qualified Individuals to Participate in a Pneumonia Vaccine Clinical Trial in Birmingham, Alabama 3
... HealthDay Reporter , WEDNESDAY, Nov. 24 (HealthDay News) -- ... diagnosed until the disease is well-advanced and, therefore, less ... one-half of colorectal cancers and cervical cancers and one-third ... at a late stage, according to the report released ...
... WEDNESDAY, Nov. 24 (HealthDay News) -- A study conducted ... for blacks than it is for whites. In fact, ... one-fifth higher than it is for whites in that state. ... on Smoking and Health at the U.S. Centers for Disease ...
... London, UK, 24 November 2010 Research from ... ( http://www2.i-med.ac.at/psychlab/ ) at the Medical University Innsbruck ... in rats exhibited pathologies similar to Alzheimer,s disease. ... Neuroscience (45(4):408-417, 2010) with lead author Dr. ...
... holder of endowed chair during a research symposium at Children,s ... A. DeClerck, MD, professor of Pediatrics, Biochemistry and Molecular Biology ... Southern California has been inducted as the inaugural holder of ... "My family has long been dedicated to improving the ...
... 24 (HealthDay News) -- If you are one of the ... a few simple steps can help reduce your stress on ... School of Nursing at Binghamton University, State University of New ... items well ahead of time and have a list ready ...
... HealthDay Reporter , TUESDAY, Nov. 23 (HealthDay News) -- A ... 44 percent in those at highest risk for contracting the virus, ... finds. The reduction in risk climbed to nearly 73 percent ... of the time, the researchers added. Truvada is already available ...
Cached Medicine News:Health News:Too Many Cancers Still Spotted Too Late: CDC 2Health News:Too Many Cancers Still Spotted Too Late: CDC 3Health News:Black Smokers May Face Higher Death Risk Than Whites: CDC 2Health News:Chronic high cholesterol diet produces brain damage 2Health News:Richard Call Family Endowed Chair honors Dr. Yves DeClerck at the Saban Research Institute Symposium 2Health News:Daily Pill Lowers Odds for Infection With HIV 2Health News:Daily Pill Lowers Odds for Infection With HIV 3Health News:Daily Pill Lowers Odds for Infection With HIV 4
The ADx system uses fluorescence polarization immunoassay technology for the detection of abused drugs and toxicology assays....
Innotrac Aio! immunoanalyzers are specially designed to exploit the benefits of Innotrac Diagnostics' exclusive dry chemistry and non-enhancement time-resolved fluorometry....
... The Access immunoassay system ... access benchtop analyzer that ... assays, with panels that ... thyroid, infectious disease, blood ...
...
Medicine Products: