Navigation Links
FDA Determines VYVANSE(R) was Properly Granted Five-Year Market Exclusivity
Date:10/26/2009

DUBLIN, October 26 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the Food and Drug Administration (FDA), following a thorough administrative review of governing statutory and regulatory standards and public comments, has affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S. Inc. for the treatment of attention-deficit hyperactivity disorder under the name VYVANSE(R). The five-year exclusivity period for VYVANSE expires on February 23, 2012. VYVANSE is covered by United States patents which remain in effect until June 29, 2023.

On February 23, 2007, after reviewing the requisite clinical studies submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as a NCE and was entitled to five-year market exclusivity. The FDA therefore appropriately refused to file the Abbreviated New Drug Application submitted by Actavis Elizabeth, LLC (Actavis) for generic lisdexamfetamine dimesylate in January 2009. On February 24, 2009, Actavis sued the FDA in the District Court of the District of Columbia challenging the NCE decision. On April 13, 2009, the FDA opened a public docket to consider Actavis's challenge to the FDA's regulations governing NCE exclusivity and the corresponding award of exclusivity to VYVANSE. The court case was stayed pending the outcome of this FDA review.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Study Published in Journal of Clinical Psychiatry Showed Once-Daily VYVANSE(R) (lisdexamfetamine dimesylate) Significantly Improved ADHD Symptoms in One of the Largest Controlled Stimulant Trials in Adults with ADHD
2. Recent Study Demonstrated VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Improvements in Behavior, Inattention, and Math Test Scores from 1.5 Hours up to 13 Hours following Administration in Children with ADHD
3. New Study Evaluating the ADHD Medication VYVANSE(R) (lisdexamfetamine dimesylate) CII Demonstrated No Change in the Pharmacokinetic Profile of VYVANSE When Coadministered with Prilosec OTC(R) 40 mg (20 mg X 2), a Commonly Used Proton Pump Inhibitor (PPI)
4. Dallas Researchers Find Compression Stockings Improperly Used
5. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
6. Pharmion and MethylGene Announce U.S. Orphan Drug Designation Granted for MGCD0103 for the Treatment of Hodgkins Lymphoma
7. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
8. Taxotere(R) (docetaxel) Granted FDA Approval to Treat Locally Advanced Head and Neck Cancer Prior to Chemoradiotherapy and Surgery
9. Aptivus(R) (tipranavir) Capsules Granted Full Approval by the U.S. FDA
10. Authorization for AGENDA Phase 3 Trial of Genasense(R) in Advanced Melanoma Granted by French Regulatory Agency
11. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... DETROIT , April 17, 2015  In Detroit, where ... infant mortality rate is two and one half times of ... Nearly 6 of 10 infants that die in ... are sobering statistics that Covenant Community Care, a faith-based, charitable ... is poised to change thanks to a charitable donation by ...
(Date:4/17/2015)...  Over the next five years, the marijuana industry in ... predicting that 14 more states will legalize recreational marijuana and ... for legal cannabis grew 74 percent in 2014 to $2.7 ... market could grow more than fourfold to $11 billion in ... on marijuana. Cannabiz Mobile Inc. (OTCBB: LGBI) is ...
(Date:4/17/2015)... Apr. 16, 2015 Research and Markets ... "Corporate Reputation of Pharma in 2014 - a ... report to their offering. This independent study, ... patient groups with an interest in diabetes on the ... the pharma industry as a whole) in 2014. The ...
Breaking Medicine Technology:Covenant Community Care to Receive Donated SONIMAGE P3 Handheld Ultrasound from Konica Minolta Medical Imaging 2Covenant Community Care to Receive Donated SONIMAGE P3 Handheld Ultrasound from Konica Minolta Medical Imaging 3Covenant Community Care to Receive Donated SONIMAGE P3 Handheld Ultrasound from Konica Minolta Medical Imaging 4Cannabiz Mobile Analyst Brief: Next Big Thing by Torus IR Issued by BrokerBank Securities, Inc. 2Perspective of Diabetes Patient Groups on the Corporate Reputation of Pharma in 2014: 130 patient groups with an interest in diabetes from 34 countries 2Perspective of Diabetes Patient Groups on the Corporate Reputation of Pharma in 2014: 130 patient groups with an interest in diabetes from 34 countries 3Perspective of Diabetes Patient Groups on the Corporate Reputation of Pharma in 2014: 130 patient groups with an interest in diabetes from 34 countries 4Perspective of Diabetes Patient Groups on the Corporate Reputation of Pharma in 2014: 130 patient groups with an interest in diabetes from 34 countries 5
... Montenegro, Serbia,... -- BOZEN, Sud-Tirol, Italy, October 11, 2010 ... ... --> ... { var s = ,; var first_result; // Results are keyed by longUrl, so we need ...
... MONTGOMERY, Ala., Oct. 11 Health Care Systems, ... 4, is 2011/2012 compliant and was certified as ... Commission for Health Information Technology (CCHIT®), an ONC-ATCB, ... adopted by the Secretary of Health and Human ...
Cached Medicine Technology:Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 2Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 3Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 4Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 5Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 6Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 7Health Robotics Expands Operations Into Bosnia, Croatia, Finland, Macedonia, Montenegro, Serbia, and Slovenia 8Health Care Systems, Inc.'s HCS eMR Receives ONC-ATCB 2011/2012 Certification 2Health Care Systems, Inc.'s HCS eMR Receives ONC-ATCB 2011/2012 Certification 3Health Care Systems, Inc.'s HCS eMR Receives ONC-ATCB 2011/2012 Certification 4
(Date:4/17/2015)... 2015 Testosterone treatment lawsuits ( ... prescription medications increases the likelihood that a man ... life-threatening cardiovascular event continue to mount in a ... District of Illinois. According to an updated Statistics ... Multidistrict Litigation (JPML) on April 15th, 1,382 cases ...
(Date:4/17/2015)... Scientists from the Icahn School ... U.S. and Venezuelan researchers, have discovered the most ... an isolated tribe of Yanomami Amerindians in the ... the Yanomami, previously unexposed to antibiotics or industrialized ... of people living in industrialized countries, and was ...
(Date:4/17/2015)... Bronx, NY (PRWEB) April 17, 2015 Calvary ... Calvary Fund, Inc. as Executive Vice President on May 11. ... Hospital’s unique and historic mission. Barr succeeds Vincent J. Spinelli, ... Tim has agreed to take on and supervise the important ... Calamari, president and CEO. “As Calvary continues to expand and ...
(Date:4/17/2015)... NJ (PRWEB) April 17, 2015 ... in the posterior pituitary and thought to help mothers ... between couples. To further substantiate this, new studies performed, ... the journal, Nature, and reported by Medical News Today ... a powerful influence over maternal social behavior. The study ...
(Date:4/17/2015)... Mario Badescu Botanical Exfoliating ... facial skin with its unique combination of finely ... energizing botanicals. This cushiony gel-based formula sloughs off ... and inhibit penetration of special treatments, serums, and ... Seeds, This uncommon exfoliating ingredient is an ecologically ...
Breaking Medicine News(10 mins):Health News:Testosterone Treatment Lawsuits Increase, as New Report Indicates Over 200 Federal Cases Filed Since March 2Health News:Testosterone Treatment Lawsuits Increase, as New Report Indicates Over 200 Federal Cases Filed Since March 3Health News:Testosterone Treatment Lawsuits Increase, as New Report Indicates Over 200 Federal Cases Filed Since March 4Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 2Health News:Mount Sinai Scientists Find Unprecedented Microbial Diversity in Isolated Amazonian Tribe Previously Unexposed to Antibiotics or Processed Foods 3Health News:Timothy P. Barr Appointed Executive Vice President of Calvary Fund 2Health News:Timothy P. Barr Appointed Executive Vice President of Calvary Fund 3Health News:Oxytocin Now Found to Help Diet Doc Patients Whose Weight Has Gotten out of Control Due to Emotional Eating Disorders 2Health News:Oxytocin Now Found to Help Diet Doc Patients Whose Weight Has Gotten out of Control Due to Emotional Eating Disorders 3Health News:Mario Badescu Skin Care Launches Botanical Exfoliating Scrub 2
... As hooking up takes over from dating as a means ... continue to prefer dating whereas more men than women rate ... and risks to dating and hooking up. Carolyn Bradshaw from ... reasons that motivate college men and women to hook up ...
... this as troubling individually and for society , WEDNESDAY, ... mobility are increasing among middle-age Americans, a new study ... long-term consequences for the U.S. health-care system. , Researchers ... data from the annual National Health Interview Survey, covering ...
... Home ... to create, save and export HH CAHPS Survey data for three leading HH CAHPS ... , ... 7, 2010 -- Kinnser Software, Inc. introduces a new service enabling home health agencies ...
... ... tested for reliable operation in the most extreme environments. This rugged system uses a ... daylight. The SDC100HB is specifically designed for the uncompromising requirements of applications in the ... ...
... ... The Centers for Disease Control advise that even after being rinsed ... exposed to more germs now than in the past decades and ... exposure and infection. ,DrTung’s new kids’ snap-on toothbrush sanitizer uses lions ...
... Mount Sinai researchers of over eight years of dietary data ... between high consumption of fruits and vegetables and a reduced ... The study is published online April 6, 2010 in the ... is widely believed that a diet rich in fruits and ...
Cached Medicine News:Health News:Hooking up or dating: Who benefits? 2Health News:Middle-Age Americans Less Mobile Than Ever 2Health News:Kinnser Software Supports HH CAHPS Survey Data Export to Three Approved HH CAHPS Survey Vendors 2Health News:Kinnser Software Supports HH CAHPS Survey Data Export to Three Approved HH CAHPS Survey Vendors 3Health News:Kinnser Software Supports HH CAHPS Survey Data Export to Three Approved HH CAHPS Survey Vendors 4Health News:Rugged High Bright Touch Screen Computer Designed and Tested for the Most Extreme Environments 2Health News:Rugged High Bright Touch Screen Computer Designed and Tested for the Most Extreme Environments 3Health News:'Animals' Keep Germs Away From Kids' Toothbrushes 2Health News:Mount Sinai study finds only a weak link between fruit and vegetable and reduced risk of cancer 2
... AccuGENE Molecular Biology Buffers are ready-to-use ... molecular biology applications. Each reagent is prepared ... 0.2 micron filter, and filled into sterile ... strict quality control standards to ensure lot-to-lot ...
1.2% Tryptone, 2.4% Yeast Extract, 0.4% Glycerol, with 100ml of 10x Phosphate buffer supplement (0190-01)....
1.0% Casein digest (NZ amine), 0.5% Sodium Chloride....
S.O.C. Medium...
Medicine Products: