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:6/26/2016)... -- Story Highlights: , ... health care industry is causing providers to review operating ... offers a suite of solutions for health care providers ... optimization: labor resource analysis, revenue cycle optimization and physician ... and better economics ...
(Date:6/24/2016)... CAMBRIDGE, Mass. , June 24, 2016 /PRNewswire/ ... the Spaulding Rehabilitation Network,s Dean Center for ... of Physical Medicine and Rehabilitation, MIT Hacking Medicine, ... Center for Innovation, today announced the five finalists ... Hackathon for Lyme disease.  More than 100 scientists, ...
(Date:6/24/2016)... 24, 2016 Dehaier Medical Systems Ltd. (NASDAQ: ... develops, markets and sells medical devices and wearable sleep ... a strategic cooperation agreement with Hongyuan Supply Chain Management ... on June 20, 2016, to develop Dehaier,s new Internet ... agreement, Dehaier will leverage Hongyuan Supply Chain,s sales platform ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... ... ... of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum Wage’ ... 2020 and then adjusting it yearly to increase at the same rate as the median ... floor does not erode again, and make future increases more predictable. , The company is ...
Breaking Medicine News(10 mins):