Navigation Links
Shire Update on ProAmatine(R) (midodrine HCl)
Date:9/13/2010

Shire Update on ProAmatine(R) (midodrine HCl) -- PHILADELPHIA, September 13, 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
Health Care & Hospitals, Health Insurance, Pharmaceuticals Click to view news release full screen  

Shire Update on ProAmatine(R) (midodrine HCl)

   

FDA Posts Clarifying Statement on its Website

PHILADELPHIA, September 13, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that the United States Food and Drug Administration today posted an update on its website related to ProAmatine (known generically as midodrine), a medicine approved for the treatment of symptomatic orthostatic hypotension. Notably, the FDA clarified that the FDA's prior announcement related to midodrine "did not represent the actual withdrawal of the medication from the market." Rather, the FDA stated that it "represented a step in the regulatory process."

To view this FDA statement, visit: http://www.fda.gov/Drugs/DrugSafety/ucm225444.htm

"Shire is very pleased that FDA has stated that 'continued patient access to midodrine is a key agency priority' and that the FDA has taken action allowing midodrine to remain accessible to patients and their families who rely on this medicine," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire. "We look forward to continuing our ongoing discussions with FDA related to the efficacy of this medicine."

Important Safety Information

Warning: Because ProAmatine(R) can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of ProAmatine(R) in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine(R), principally improved ability to carry out activities of daily living, have not been verified.

CONTRAINDICATIONS

ProAmatine(R) is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. ProAmatine(R) should not be used in patients with persistent and excessive supine hypertension.

Please see Full Prescribing Information (http://www.shire.com/shireplc/en/products/about_PROAMATINE)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088.

For further information please contact:

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.

Investor Eric Rojas (erojas@shire.com) +1-781-482-0999 Relations Media Jessica Mann (jmann@shire.com) +44-(0)1256-894-280 Matthew Cabrey (mcabrey@shire.com) +1-484-595-8248
'/>"/>

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

Related medicine technology :

1. Shire Announces Support for Inflammatory Bowel Disease (IBD) Fellowships at Leading Medical Institutions Nationwide
2. Pentasa(R) - Shire Receives Ruling From FDA on Citizens Petition
3. Shire Purchases Strategic Site in Massachusetts
4. Shire Receives LIALDA(R) Paragraph IV Notice Letter From Zydus Pharmaceuticals
5. Area Residents Can Give a Little, Help A Lot at Shires BIG GIVE
6. Shire Receives INTUNIV(TM) Paragraph IV Notice Letter From Anchen
7. Excellent Results in a Transformational Year for Shire; Core Product Sales up 25%
8. Shire Presents Positive Efficacy and Safety Data for velaglucerase alfa in Treatment of Naive Patients With Type 1 Gaucher Disease
9. Shire Submits Biologics License Application (BLA) for REPLAGAL(R) With the U.S. Food and Drug Administration (FDA)
10. Shire Expands its Award-Winning ADHD Support Resource, ADHDSupport.com, by Launching an ADHD Twitter(TM) Page
11. Shire and Teva Settle Litigation Concerning Supply of ADDERALL XR Authorized Generic
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/16/2017)... WAYNE, N.J. , June 16, 2017 Datascope Corp. ... sold by Datascope Corp. for a potential electrical test failure code.     ... PRODUCT PART NUMBER ... CS100 IABP CS300 IABP ... ...
(Date:6/13/2017)... June 13, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... announced that the U.S. Food and Drug Administration (FDA) has ... 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning Letter related ... facility is a measure of the progress we have made ...
(Date:6/9/2017)... , June 9, 2017 More than 400 ... effort to help spread lessons learned from clinical research ... Diabetes Federation (IDF) and Eli Lilly and Company (NYSE: ... second phase of the Bringing Research in Diabetes to ... commitment to helping people with diabetes effectively manage their ...
Breaking Medicine Technology:
(Date:6/23/2017)... , ... June 23, 2017 , ... ... Act (BCRA), their proposed healthcare bill to repeal and replace the Affordable Care ... Senate bill would make significant cuts to Medicaid, a public health insurance program ...
(Date:6/23/2017)... ... June 23, 2017 , ... Everybody has their own ... others prefer to read it, and some people don't like it at all. FindaTopDoc ... what they found: , Erotic literature can give readers a taste of their deepest, ...
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and South Asia Leaders ... leaders from government, business and civil society in 11 countries across the Middle East ... engaging in a transformative exchange of knowledge and ideas with the leading minds in ...
(Date:6/23/2017)... (PRWEB) , ... June 23, 2017 , ... Ulster University, ... June, 2017 from 9 am to 3 pm to present to graduate students exciting ... is an original curriculum project led by The Health Improvement Service of the ...
(Date:6/23/2017)... ... June 23, 2017 , ... Moore Insurance, an eastern ... access to asset protection and financial planning services, is teaming up with the ... lives of children with cancer and other chronic diseases. , The For A ...
Breaking Medicine News(10 mins):