Navigation Links
FDA Approves Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Date:11/15/2010

PHILADELPHIA, Nov. 15, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) approved the prescription medication Vyvanse® (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents ages 13 to 17.  The approval is based on study data demonstrating that Vyvanse improved ADHD symptoms compared to placebo in adolescents with ADHD. Vyvanse is also indicated for the treatment of ADHD in children ages 6 to 12 years, and adults.

"This adolescent indication for Vyvanse is good news for kids in this age group diagnosed with ADHD and their caregivers as it offers an additional treatment option to help them manage their symptoms," said Mike Yasick, Senior Vice President of Shire's ADHD Business.  "The approval of Vyvanse for children and adults – and now for adolescents – underscores Shire's commitment to helping ADHD patients and their families."  

The FDA's approval of Vyvanse in adolescents was based on results from a randomized, double-blind, placebo-controlled, four-week, forced-dose escalation study of adolescents who received one of three Vyvanse doses, 30, 50 and 70 mg/day, or a placebo.  This study was conducted in 314 adolescents aged 13 to 17 who met DSM-IV-TR® criteria for ADHD.  In this study, patients were randomized to a daily morning dose of Vyvanse (30 mg/day, 50 mg/day or 70 mg/day) or placebo for a total of four weeks of treatment.  All subjects receiving Vyvanse were initiated on 30 mg for the first week of treatment. Subjects assigned to the 50 mg and 70 mg dose groups were escalated
'/>"/>

SOURCE Shire plc
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. FDA Approves Cymbalta® for the Management of Chronic Musculoskeletal Pain
2. FDA Approves New Indication for Afinitor
3. FDA Approves Teflaro for Bacterial Infections
4. FDA Approves Latuda to Treat Schizophrenia in Adults
5. FDA Approves Additional Medical Indication for Sprycel
6. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
7. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
8. FDA Approves Botox to Treat Chronic Migraine
9. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
10. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
11. FDA Approves Combination Contraceptive Containing a Folate
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/22/2014)... Research and Markets  has announced the addition ... 2014-2017" report to their offering. ... protein drug market has been expanding rapidly owing to ... like. During 2005-2013, sales of recombinant protein drugs available ... 19.1%, and it is projected that ...
(Date:11/21/2014)... CORONA, Calif. and VIENNA, Va. ... an innovative in-home care provider that operates in ... with BeClose, a leading provider of remote caregiving technology. Alta ... new and existing client receiving homecare services. ... believe this technology is the key to providing the ...
(Date:11/21/2014)... , Nov. 21, 2014  World Hemp Oil, an ... THC, announces they are now offering legal, organic oil ... Web type strains grown in medical marijuana states. People ... disorders, such as Parkinson,s, MS, and spinal cord injury, ... to pass, because imported CBD Oil Is legal in ...
Breaking Medicine Technology:China Recombinant Protein Drug Industry Report, 2014-2017 2China Recombinant Protein Drug Industry Report, 2014-2017 3Alta Home Care, Inc. and BeClose Partner to Enable Seniors to Remain in Their Homes Safely and Securely 2New CBD Oil From Industrial Hemp is Comparable to Charlotte's Web, Legal In All 50 States 2New CBD Oil From Industrial Hemp is Comparable to Charlotte's Web, Legal In All 50 States 3
... N.J., Dec. 9, 2011  Saint-Gobain Performance Plastics has upgraded ... new state-of-the art laser engraving system. The system ... or tag of all hose assemblies, piping and ... Saint-Gobain Performance Plastics can engrave crimp collars on ...
... 2011 Gen-Probe Incorporated (NASDAQ: GPRO ) announced today ... Conference in New York on December 14, 2011 at approximately 10:15 ... and may be accessed through a link on the investors section ... available for 30 days following the event. ...
Cached Medicine Technology:Saint-Gobain Introduces Laser Engraving for Hose Assemblies 2Gen-Probe to Webcast Presentation at the Oppenheimer 22nd Annual Healthcare Conference 2
(Date:11/24/2014)... Volpara Solutions announced today that it ... Annual Meeting of the Radiology Society of North ... 1752 – South Hall). Volpara Solutions will showcase ... of its innovative suite of quantitative breast imaging ... measurements of volumetric density, patient-specific dose, breast compression ...
(Date:11/24/2014)... Recently, SweetDressy.com, a well-known dress supplier and leader in ... Evening Dresses. All these fresh items are offered at ... the special offer is valid until Dec. 20, 2014. ... been working well in the fashion industry for years. ... new dresses may be the best products for many ...
(Date:11/24/2014)... 2014 SafeHandles™ announced that they will ... Ed Begley Jr, airing via Discovery Channel. Dates and ... a passive, non-invasive, replaceable, and affordable germ protective device. ... shrinkable sleeves and adhesives to promote hand hygiene in ... core of SafeHandles is the desire to make a ...
(Date:11/23/2014)... The clinical trial report, "Aspergillosis ... on the Aspergillosis clinical trial scenario. This report ... clinical trials on Aspergillosis. It includes an overview ... as per the site of trial conduction across ... of disease clinical trials by their phase, trial ...
(Date:11/23/2014)... Pro Ace Care, a renowned Vancouver hot water tank company, ... 8 year warranty on its selected hot water tanks. As ... to the impending winter season, it was important for Pro ... that the company provides. As a result, Pro Ace will ... Bradford hot water tanks. , “Every installer who works ...
Breaking Medicine News(10 mins):Health News:Volpara Solutions to Launch VolparaAnalytics 1.2 at RSNA 2Health News:Volpara Solutions to Launch VolparaAnalytics 1.2 at RSNA 3Health News:SweetDressy.com Unveiled A New Selection Of Evening Dresses 2Health News:New Episode of Innovations TV Series to Feature SafeHandles™ 2Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 2Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 3Health News:Aspergillosis Pipeline and Clinical Trials Market (Compnies and Drugs) Review H2 2014 Report at ReportsnReports.com 4Health News:Pro Ace Care Now Gives 8 Year Guarantee on Selected Vancouver Hot Water Tanks 2
... people who are unlikely to incur high medical expenses. ... families, finds a study of Massachusetts families from Children,s ... Care and Prevention (DACP). The study appears in the ... The researchers, led by Alison Galbraith, MD, MPH, and ...
... survive severe injuries on battlefields such as those in ... infections of their wounds with multidrug resistant bacteria. The ... Staphylococcus aureus (MRSA), Acinetobacter baumannii , ... coli . , Dr Clinton K. Murray, from Brooke ...
... to create open access to information that will enhance ... ORLANDO, Fla., March 29 /PRNewswire/ -- ... GE Healthcare,s Cardiovascular Ultrasound unit announced a formal affiliation ... an integrated solution aimed at improving workflow for echocardiography ...
... allergen breathed in by a person with asthma triggers a ... events to prompt an allergic reaction, said a consortium of ... in Houston in a report that appears online today in ... activates interleukin 25, a key mediator of the allergic response ...
... Relaxin cuts shortness of breath and trimmed hospital stays, phase ... The hormone relaxin reduces shortness of breath and cardiovascular death ... pressure, according to a phase 2 trial conducted in eight ... a few hours of arriving at a hospital, were randomly ...
... Doctor urges first responders to clean equipment regularly ... News) -- One in three stethoscopes used by ... methicillin-resistant Staphylococcus aureus (MRSA) bacteria, a new study ... and Dentistry of New Jersey swabbed 50 stethoscopes ...
Cached Medicine News:Health News:Low-income families with sick children often enrolled in high-deductible health care plans 2Health News:ProSolv CardioVascular and GE Healthcare Ultrasound Division Announce Affiliation 2Health News:ProSolv CardioVascular and GE Healthcare Ultrasound Division Announce Affiliation 3Health News:Hormone Reduces Mortality in Heart Patients With High BP 2Health News:Third of EMS Stethoscopes Carry MRSA Bacterium 2
Inquire...
Inquire...
Inquire...
... a range of 18 Ophthalmic frames ... and producted to the very hightest ... super lightweight Titanium and Beta Titanium ... host of beautifully formed and innovative ...
Medicine Products: