Navigation Links
Shire to Initiate Two Phase 4 Clinical Trials to Compare Vyvanse® (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)
Date:3/6/2012

sdexamfetamine dimesylate)

Vyvanse, which was introduced in the United States in July 2007 for the treatment of ADHD in children ages 6 to 12 years, approved in April 2008 to treat ADHD in adults, and approved in November 2010 to treat ADHD in adolescents ages 13 to 17, is currently available in six once-daily dosage strengths of 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Additional information about Vyvanse is available at http://www.vyvanse.com.

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above as part of a total treatment plan that may include other measures (psychological, educational, social). Efficacy was established in short-term controlled studies in children aged 6 to 17 and adults. Vyvanse is also approved as a maintenance treatment for adults with ADHD based on one randomized withdrawal study. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION

See Full Prescribing Information for complete Boxed WARNING.

• Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion.

• Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.

Contraindications: Known hypersensitivity to amphetamines or other ingredients in Vyvanse.

Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors (MAOIs) can result in hypertensive crisis. Stop MAOIs at least 14 days prior to Vyvanse use.

Sudden death, stroke and myocardial infarction have
'/>"/>

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

Page: 1 2 3 4 5 6 7

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires 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
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... AARP Foundation today announced it has established a relief ... cold weather that has gripped much of the nation. AARP ... so to support these emergency relief efforts AARP and AARP ... mean up to $500,000 in aid. The matching program will ...
(Date:1/15/2014)... 15, 2014 Shire plc (LSE: SHP, NASDAQ: ... Fair Trading (OFT) approval condition to the announced tender offer for ... As a result of the waiver, the transaction is ... the tender offer on January 24, 2014 following the currently scheduled ...
(Date:1/15/2014)... , Jan. 15, 2014  In an unprecedented effort to curb ... in ambulances and other transport vehicles, an advanced and portable UV ... personnel for the first time. In order to ... these deadly pathogens, West Palm Beach Fire ...
Breaking Medicine Technology:AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 2AARP Foundation Establishes Winter Relief Fund for Older Adults Suffering from the Severe Cold Weather 3Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3Superbugs No Longer Ride In Rescue Vehicles 2
(Date:7/9/2014)... WASHINGTON, DC (July 10, 2014) If you think winning ... fun for kids think again: Winning along with other mental ... each of which falls into one of 11 big fun ... that winning is all important when it comes to the ... identify and quantify what goes into this elusive conceptuntil now. ...
(Date:7/9/2014)... the first time, researchers have access to detailed information ... health care. A new study, called Our Health Counts, ... challenges faced by urban Aboriginal people in Canada ... The findings, published today in BMJ Open , ... the general population. , Researchers interviewed 554 First Nations ...
(Date:7/9/2014)... After Susan Wakulich was told she had an aneurysm, she ... of her. , "I was devastated," said Wakulich, who is ... knew this was a serious diagnosis. Then I met Dr. ... involved a less invasive procedure. It was something I didn,t ... in a multi-center U.S. clinical trial to evaluate the safety ...
(Date:7/9/2014)... cancer, researchers have uncovered mutations in a cell-signaling pathway ... knowledge may expand treatments for patients because drugs targeting ... are in clinical trials. , Reporting July 9 in ... (TCGA), including researchers at Washington University School of Medicine ... studied tumors from 230 patients with lung adenocarcinoma. , ...
(Date:7/9/2014)... PROVIDENCE, R.I. Researchers have found that fecal ... difficile in immunocompromised patients. This is the result ... gastroenterologist in the Center for Women,s Gastrointestinal Medicine at ... have been published online in advance of print in ... Clostridium difficile , or C. diff , has ...
Breaking Medicine News(10 mins):Health News:Being a good sport ranks as the top 'fun' factor in study of youth sports 2Health News:Being a good sport ranks as the top 'fun' factor in study of youth sports 3Health News:Urban Aboriginal people face unique health challenges 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Lung cancer study hints at new treatments 2Health News:Women's Medicine Collaborative examines safety of fecal transplant to treat C. difficile 2
... all set to start its manufacturing facility in ... Japanese drug market. ,Ind-Swift Laboratories has ... for its Clarithromycin active pharmaceutical ingredient (API) manufacturing ... Thursday. ,Clarithromycin is a macrolide antibiotic ...
... Singh (SMS) medical college here will set up a stem ... genetics// and stem cells. ,The laboratory, to be ... the state government-run institute, has been taken up under an ... and technology. ,Ashok Pangariya, principal of the SMS ...
... has been urged to redouble its efforts in the fight against ... Joint United Nations program on HIV/AIDS, comes after Fiji's Ministry of ... living with HIV and AIDS, reported Fijilive Thursday. ,The ... to 25 in 2005 and four cases in 1996. ...
... Seven industrialized nations on Friday plans to sign an ... //diseases - including HIV/AIDS, TB //and malaria - that ... on Tuesday. ,Under the program, donor ... developed at a preferential price when they are available. ...
... Technion-Israel Institute of Technology have figured out a way ... into a guided missile that strikes specifically at a ... ,Professor Amram Mor of the Biotechnology and ... peptide, a small molecule made of short chains of ...
... Drug Administration has approved the sale of a diet drug which can ... which was previously sold as a prescription drug by the name Xenical ... be sold in 60 mg capsules while Xenical was sold in 120 ... it is said to be very effective. The price is expected to ...
Cached Medicine News:Health News:Stem Cell Research Lab Coming Up in Jaipur 2Health News:Bacteria Fighter Goes Where Antibiotics Can't 2
... The Sysmex pocH-100i is the first Sysmex ... low daily testing requirements. With its small ... differential from just 15 L of whole ... any small healthcare site including the emergency ...
... a self-contained, compact, easy-to-use, bedside automated cell ... Ichor system provides a hematology profile of ... platelet aggregation within five minutes. The test ... is added to both an EDTA baseline ...
... pacemaker family, which includes the world's ... the most advanced pacemaker technology available, ... the first and only U.S. commercially ... fibrillation (AF). The AF Suppression algorithm ...
... catheters that are controlled by an ... console processes the refrigerant, which when ... the catheter, creates cryogenic temperatures., ,The ... touch-screen interface. From this interface, the ...
Medicine Products: