Navigation Links
Shire plc - Statement re ProAmatine
Date:8/17/2010

Shire plc - Statement re ProAmatine -- PHILADELPHIA, Pennsylvania, August 17, 2010 /PRNewswire-FirstCall/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Biotechnology, Health Care & Hospitals, Medical Pharmaceuticals, Acquisitions, Mergers and Takeovers, Clinical Trials & Medical Discoveries, FDA Approval Click to view news release full screen  

Shire plc - Statement re ProAmatine

 

PHILADELPHIA, Pennsylvania, August 17, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) acquired ProAmatine as a part of the acquisition of Roberts Pharma in 1999 and Shire conducted and completed the post marketing trials that the FDA required. The FDA, however, viewed these trials as inconclusive and required that additional trials be conducted for ProAmatine to maintain its marketing authorization. As a result, Shire elected to withdraw the product effective September 30, 2010 and notified the FDA in November 2009 and healthcare professionals earlier this year of this decision. Shire's withdrawal of the NDA was not related to any concerns regarding the safety of ProAmatine.

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 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 Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate 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: Media Matthew Cabrey (mcabrey@shire.com) +1-610-613-2790 Ben Atwell (Ben.Atwell@fd.com) +44-020-7269-7242
'/>"/>

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

Related biology technology :

1. Shire Proposes to Expand Specialist Gastrointestinal Portfolio
2. Lialda(R) - Shire Files Suit Against Cadila Healthcare Limited, Doing Business as Zydus Cadila and Zydus Pharmaceuticals (USA), Inc.
3. Shire Receives CHMP Positive Opinion for VPRIV(TM) (velaglucerase alfa) for the Treatment of Type 1 Gaucher Disease in the European Union
4. Shire plc Appoints Two New Board Directors
5. INTUNIV(TM) - Shire Files Suit Against Anchen Pharmaceuticals, Inc. and Anchen, Inc.
6. Shire Receives 2010 Corporate Award From the National Organization for Rare Disorders (NORD) for the Development of VPRIV (velaglucerase alfa for Injection)
7. INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.
8. Shires Replenished Portfolio Drives Excellent Quarterly Performance
9. Shire Receives INTUNIV (TM) Paragraph IV Notice Letter From Teva Pharmaceuticals
10. Shire Supports Rare Disease Day 2010
11. Shire Announces FDA Approval of VPRIV(TM) (velaglucerase alfa for injection) for the Treatment of Type 1 Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/24/2017)... KNOXVILLE, Tenn. , Feb. 24, 2017 /PRNewswire/ ... ) ("Provectus" or the "Company"), a clinical-stage oncology ... information regarding the deadline to participate in its ... million units, consisting of shares of common stock ... stockholders and holders of listed warrants. ...
(Date:2/24/2017)... Symic Bio, a biopharmaceutical company focused on ... therapeutics, announced today the completion of enrollment for the ... The trial will evaluate the safety and efficacy of ... of restenosis following angioplasty. "We,re pleased ... said Nathan Bachtell , M.D., Chief Medical Officer ...
(Date:2/24/2017)... China Cord Blood Corporation (NYSE: CO ) ... blood collection, laboratory testing, hematopoietic stem cell processing and ... results for the third quarter and first nine months ... Third Quarter of Fiscal 2017 Highlights ... increased by 18.6% to RMB200.9 million ($28.9 million). ...
(Date:2/24/2017)... Biologic Products, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), ... announced its financial results for the fourth quarter and fiscal ... Highlights Total sales in the fourth ... increased by 13.6% in USD terms to $77.6 million from ... Gross profit increased by 13.3% to $46.8 million from ...
Breaking Biology Technology:
(Date:1/30/2017)... , Jan. 30, 2017   Invitae Corporation ... fastest growing genetic information companies, today announced that it ... results and provide 2017 guidance on Monday, February 13, ... call that day at 4:45 p.m. Eastern / 1:45 ... management team will briefly review financial results, guidance, and ...
(Date:1/25/2017)... 25, 2017 The Elements of Enterprise Information ... is comprised of a comprehensive set of business ... maintaining digital identities and providing a secured and ... are significant number of programs opted by enterprises ... by optimizing processes and changing policies. However, there ...
(Date:1/23/2017)... latest mobile market research from Acuity Market Intelligence reveals ... average price of a biometric smartphone decreased from $849 ... are now 120 sub-$150 models on the market at ... a year ago at an average price of $127. ... Acuity Market Intelligence Principal, "Biometric Smartphones are a global ...
Breaking Biology News(10 mins):