Navigation Links
Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR
Date:6/23/2012

PHILADELPHIA, June 23, 2012 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that on June 22, 2012, the US Food and Drug Administration (FDA) responded to Shire's Adderall XR citizen petition. The FDA's response requires that all abbreviated new drug applications (ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products.

The FDA also informed Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.

Shire believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Teva and Impax.  While recognizing that there will be multiple dynamics affecting the overall market following the approval of the Actavis generic, Shire continues to believe that it will deliver good, full year 2012 earnings growth.

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, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions.  Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights.  Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: http://www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

For further information please contact:

Investor Relations:        
Eric Rojas    
erojas@shire.com
+1-781-482-0999

Sarah Elton-Farr    
seltonfarr@shire.com
+44-1256-894157

Media:        
Jessica Mann (Corporate)    
jmann@shire.com
+44-1256-894-280

Gwen Fisher (Specialty Pharma)    
gfisher@shire.com
+1-484-595-9836


'/>"/>
SOURCE Shire plc
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Shire to Present Scientific Data Across Range of Psychiatric Disorders at American Psychiatric Association Annual Meeting May 5-9
2. Shire Delivers Strong First Quarter Performance and Reiterates its Expectation of Good Full Year Earnings Growth
3. Maroon 5 Lead Singer Adam Levine and Shire Announce "The Own It Project," Encouraging Adults with Attention-Deficit/Hyperactivity Disorder to Tell Their Stories Through a National Contest
4. ERT Announces Stockholder Approval of Merger
5. Biodel Announces $18.5 Million Private Placement
6. BioElectronics Corporation Announces Indian Distributors Ecommerce Website
7. Marken Announces Global Advisory Board
8. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
9. Generex Announces Results of Annual Stockholders Meeting
10. SCOLR Pharma Announces Unaudited Net Sales of Nutritional Products
11. Scioderm Announces Positive Phase II Data of Topical SD-101 on Wound Closure and Reduction of Lesions and Blisters in Children with Epidermolysis Bullosa (EB)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... 2, 2017 Diplomat Pharmacy, Inc. (NYSE: ... and Consulting, LLC , and named its founder as ... in Tennessee , will operate under ... EnvoyHealth,s service offerings for health care partners to include ... "In an interoperable world, technology delivers ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:10/2/2017)... , Oct. 2, 2017 The Rebound mobile ... the struggle to reverse the tide of prescription drug addiction. ... regulating their medicine intake and stepping down their dosage in ... to launch in December 2017; the first 100,000 people to ... more at http://www.rebound-solution.com/ ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Ellevate Network, the leading network for ... for action towards gender equality at their inaugural Summit in New York City in ... reached a social audience of over 3 million. To watch the Mobilize Women video, ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented ... the lowdown on sciatica in a new episode of "Success Files," which is ... events and innovation and investigates each subject in-depth with passion and integrity. , ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... “America On ... Christian identity. “America On The Brink” is the creation of published author, William ... several great-grandchildren. As a WWII veteran, he spent thirty years in the Navy. ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics ... PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... of Morris F. Collen, a pioneer in the field of medical informatics, this prestigious ...
Breaking Medicine News(10 mins):