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:10/22/2014)... Oct. 22, 2014  Cephasonics, a technology-innovation leader with ... the cQUB™-1 (cQuest Ultrasound Box™-1), the first product in ... and manufactured by Cephasonics for purchase by companies to ... Cephasonics will be showcasing the cQUB-1 for the first ... in Chongqing, China from October ...
(Date:10/22/2014)... -- Antigen Discovery Inc. (ADi), a privately held company ... receipt of a National Institutes of Health (NIH) Phase ... of Dental and Craniofacial Research (NIDCR). The one-year $225,000 ... Microarray Chip, which will contain every protein in all ... the development of safe and effective vaccines and therapies ...
(Date:10/22/2014)... LA VERNE, Calif. , Oct. 22, 2014 ... emergency readiness products, has developed APLS ® ... bag that minimizes the spread of bacteria and ... APLS Body Guard Bio features a ... and finished edges that create a leak-proof inner ...
Breaking Medicine Technology:Cephasonics Launches the cQUB-1, First Product in New Family of cQUB White-Label Ultrasound Systems Targeted at Medical Applications 2Cephasonics Launches the cQUB-1, First Product in New Family of cQUB White-Label Ultrasound Systems Targeted at Medical Applications 3Biomarker Discovery Company, Antigen Discovery Inc., Awarded an NIH Phase I Small Business Innovation Research Grant to Develop a Pan-HIV Protein Microarray Chip 2New, State-Of-The-Art Body Bag Minimizes The Spread Of Bacteria And Virus 2
... YORK, Nov. 17, 2010 Reportlinker.com announces that ... its catalogue: Global Uro-Gynecological Surgical ... This report analyzes the worldwide markets ... the following segments: Urological Surgical Devices (Sling & ...
... MedImmune announced the winners of its 5th Annual Research ... of scientific leaders performing research in areas of respiratory, ... fellows from around the world were invited to submit ... sponsored by MedImmune, AstraZeneca,s global biologics unit. ...
Cached Medicine Technology:Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 2Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 3Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 4Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 5Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 6Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 7Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 8Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 9Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 10Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 11Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 12Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 13Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 14Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 15Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 16Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 17Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 18Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 19Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 20Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 21Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 22Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 23Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 24Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 25Reportlinker Adds Global Uro-Gynecological Surgical Devices Industry 26MedImmune Announces Winners of the 5th Annual Respiratory, Inflammation and Autoimmunity Research Abstract Competition 2
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. ... three Ebola cases in Dallas. But, mental health specialists say ... President Barack Obama on Friday appointed an Ebola "czar" ... infected two Dallas nurses who cared for a Liberian man ... Hospital. But the U.S. cases are miniscule in the ...
(Date:10/22/2014)... Shriners Hospitals for Children® and UK HealthCare ... location of Shriners Hospitals for Children - Lexington from ... University of Kentucky Albert B. Chandler Hospital. The new ... and operated by Shriners Hospitals for Children, and designed ... their families well into the future. , “The quality ...
(Date:10/22/2014)... (PRWEB) October 22, 2014 Hay House is ... Beyond Addiction and Upgrade Your Life (Paperback; $10.82) written by ... Yoga & Recovery. This book is meant to help ... a life of recovery. , Recovery 2.0 is not ... Steps; Recovery 2.0 is a guide for what comes next. ...
(Date:10/22/2014)... During the Western United States’ worst ... dangerously low, Southern Oregon’s water is proving resistant to ... lowest mountain snow pack on record in 2014, remain ... autumn.* That was the observation of journalist-hikers Art Bernstein ... Southern Oregon,” during an interview with water advocate Sharon ...
(Date:10/22/2014)... Healthcare professionals who are looking for ... home or on-the-go via laptops, tablets or mobile ... premium Seminar-on-Demand CE courses. The new courses add ... hours of CE course offerings, allowing therapy ... such a diverse library, there’s something for everyone. ...
Breaking Medicine News(10 mins):Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 2Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 3Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2
... in red grapes, has been shown to improve diabetes ... has been known about how these beneficial changes are ... publication in Endocrinology , a journal of The ... role in mediating resveratrol,s anti-diabetic actions, potentially paving the ...
... ... world’s first chewable super fruit, sea vegetable, antioxidant dietary supplement, at the company’s National ... football player and Super Bowl champion with the Pittsburgh Steelers. , ... Wilmington, NC (Vocus) October 6, 2009 ...
... ... signature solution and HL7 interface for the large home health and hospice provider ... Atlanta, Ga. (PRWEB) ... largest nonprofit home healthcare and hospice provider in Georgia, has implemented the Enterprise Edition ...
... ... (Top Rank Web Designs) is building and giving away 250 Free websites to ... in doing so they have angered rivals and received a number of malicious ... competitors demanding they withdraw their offer to build these 250 free websites for ...
... Through October 31, Breads of the World, the Panera Bread ... Cancer Awareness Month by offering a Pink Ribbon Bagel -- ... and cranberries. A portion of the proceeds from each Pink ... year Panera Bread has partnered with both The Glass Thimble ...
... Donna Shalala, President of the University of Miami and former ... the featured speaker for a candid discussion on health care ... in Washington and with other critical stakeholders around the country. ... care reform in the United States. , Titled, "An ...
Cached Medicine News:Health News:Future diabetes treatment may use resveratrol to target the brain 2Health News:Jerome Bettis Endorses Chews-4-Health Dietary Supplements 2Health News:Jerome Bettis Endorses Chews-4-Health Dietary Supplements 3Health News:Visiting Nurse-Hospice Atlanta Selects PatientPlacement.com to Automate Intake and Manage Faxes 2Health News:Visiting Nurse-Hospice Atlanta Selects PatientPlacement.com to Automate Intake and Manage Faxes 3Health News:Visiting Nurse-Hospice Atlanta Selects PatientPlacement.com to Automate Intake and Manage Faxes 4Health News:SEO Consultant Top Rank Web Designs Gives Away 250 Free Websites 2Health News:SEO Consultant Top Rank Web Designs Gives Away 250 Free Websites 3Health News:SEO Consultant Top Rank Web Designs Gives Away 250 Free Websites 4Health News:Pink Ribbon Bagel Returns to Fight for a Cure 2Health News:Donna Shalala: A Candid View on Health Care Reform 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: