Navigation Links
Shire Provides Update on ProAmatine® (midodrine HCl)
Date:9/22/2011

raise blood pressure in patients with SOH.  In 2000, Shire acquired ProAmatine and completed two clinical post-marketing trials as required and submitted the results to FDA in 2005.  FDA took the position that these trials were inconclusive and requested that additional trials be completed.  Shire disagrees with the FDA and believes that these trials, together with 15 years of clinical experience, have established the clinical efficacy of ProAmatine and provide the necessary data to support the full approval of ProAmatine.

Shire has no financial interest in midodrine; Shire no longer manufactures, distributes or markets ProAmatine.  Beginning in 2003 and continuing to today, midodrine has been manufactured and distributed by five (5) generic pharmaceutical companies.  As the NDA holder, Shire has continued to invest in the needed processes to ensure this medicine remains available for patients and their families who rely on it, and Shire has worked diligently with FDA to develop a path forward that would allow the NDA to maintain its marketing authorization thus allowing the generic versions of ProAmatine to remain available for patients.  

"We look forward to continuing our discussions with FDA related to either having the agency accept the current data submitted by Shire in 2005 that demonstrates the clinical efficacy of midodrine, or agreeing on new protocols for additional studies that further confirm the clinical efficacy of ProAmatine as a treatment for patients diagnosed with SOH," added Jonas.  Important Safety InformationWarning: Because ProAmatine® 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® 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
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients
2. Shire Enhances its Orphan Drug Pipeline With the Acquisition of a New Clinical Candidate for Metachromatic Leukodystrophy
3. Shire to Present Additional Scientific Data on ADHD Treatment Portfolio at American Psychiatric Association Annual Meeting
4. Shires Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose
5. Shire Announces Approval of ELAPRASE(R) (idursulfase) in Brazil
6. Shire to add New Orphan Drug to its HGT Portfolio - EU Launch Imminent
7. Shire Withdraws European Application for DAYTRANA(TM) (Methylphenidate Transdermal System)
8. Shire Announces Study Results of the Effects of INTUNIV(TM) (Guanfacine) Extended Release on Secondary Measures in Children with ADHD and Oppositional Symptoms
9. Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week
10. Shire has Filed a Treatment Protocol for Velaglucerase Alfa for Gaucher Disease
11. Shire Receives Fast Track Designation for velaglucerase alfa for Gaucher Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/17/2014)... Oct. 17, 2014  Hanger, Inc. (NYSE: ... its results of operations for the quarter ended September ... market closes.  A conference call to discuss these results ... Friday, November 7, 2014. Those wishing to participate should ... November 14, 2014 by dialing 1-855-859-2056 and referencing Conference ...
(Date:10/17/2014)... Conn. , Oct. 17, 2014 UBM Medica ... a leading online community and information resource for neurologists ... disease and Alzheimer disease , with discussions of ... to 1 million Americans have Parkinson disease , more ... dystrophy, or Lou Gehrig disease. Diagnosis can be ...
(Date:10/17/2014)... 17, 2014 Research and Markets ... and Development Prospect of China Dialysis Market, 2014-2018" ... Based on the 2013 version, this update Report ... dialysis industry and the relevant effect in recent ... industry segmentations. Moreover, it analyzes Chinese private-owned hemodialysis ...
Breaking Medicine Technology:Neurology Times Features Coverage of Parkinson and Alzheimer Disease 2Neurology Times Features Coverage of Parkinson and Alzheimer Disease 3Research and Development Prospect of China Dialysis Market, 2014-2018 2Research and Development Prospect of China Dialysis Market, 2014-2018 3
... grounds, direct programming is superior,to cloning as a ... Nov. 20 Two major scientific,papers published this ... way to,generate patient-matched human pluripotent stem cells without ... or human or animal eggs.,Research groups in Wisconsin ...
... 20 The following statement,was released today by ... the Elizabeth Glaser Pediatric AIDS Foundation:, "Four ... Relief,(PEPFAR) began funding treatment and prevention, today,s report ... remains a devastating worldwide,pandemic, we are beginning to ...
Cached Medicine Technology:Two Major Studies Show: Human Pluripotent Stem Cells without Cloning or Destroying Embryo 2Two Major Studies Show: Human Pluripotent Stem Cells without Cloning or Destroying Embryo 3New UNAIDS Report Offers Encouraging News, But Most HIV-Positive Mothers Still Not Getting the Care & Treatment They Need 2
(Date:10/20/2014)... Myoderm announced today the ... their CentralSource service. Matthew will play ... drug sourcing, distribution, and management service for international ... of industry experience, in both business development and ... their international success to help clients manage their ...
(Date:10/20/2014)... (PRWEB) October 20, 2014 Succeed is proud ... local companies who participated in the Every Body Walk! ... a public awareness project that encourages workers to be more ... Step 10,000 Program, which concluded at the end of September, ... of cities and metro areas. Participating companies gave their ...
(Date:10/20/2014)... October 20, 2014 National Teen Driver Safety ... the American Academy of Pediatrics (Ohio AAP, http://www.ohioaap.org ) ... encouraging parents of teen drivers to talk to their teens ... , Motor vehicle crashes are the leading cause of death ... involved in fatal crashes, and 859 (42%) of those teen ...
(Date:10/20/2014)... October 20, 2014 Unveiled at the Sept. ... Direction Scorecard conservatively estimates member hospital ROI on membership dues ... dues, The Center provides $12.50 in value to member hospitals. ... Value – Member Dues)/Member Dues. , “This is the ... number and we think the methodology is really sound,” said ...
(Date:10/20/2014)... October 20, 2014 Punzoné , the ... the U.S., has a lot to celebrate this month. October ... recognizes the achievements and contributions of Americans of Italian heritage ... Punzoné, and today it shares its favorite Italian cocktails and ... to Italy - even if it is only in a ...
Breaking Medicine News(10 mins):Health News:Myoderm Hires Matthew Voicheck to Lead Turnkey Drug Sourcing Service 2Health News:Succeed Management Solutions, LLC Competes in Walking Challenge and Achieves 12th Place in Portland 2Health News:Ohio AAP Promotes National Teen Driver Safety Week 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 2Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 3Health News:Scorecard Estimates Hospital ROI at $12.50 for every $1 Spent on Dues 4Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 2Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 3Health News:Celebrate Italian Heritage Month With Authentic Cocktails from Punzoné: The Only Ultra Premium Line of Organic Imported Italian Vodka 4
... the Drugs for Neglected Diseases initiative (DNDi) today ... for leishmaniasis, Chagas disease, and sleeping sickness, three ... 10 million people worldwide. Novel drug candidates to ... development pipeline for new medicines urgently needed by ...
... Maureen Salamon HealthDay Reporter , WEDNESDAY, ... drug significantly cuts the risk of painful pancreatitis ... the digestive tract, a new study suggests. ... administered rectally after the procedure -- known as ...
... The spouses of cancer patients are at increased risk of ... said the explanation might be that stress takes a toll ... cancer registry and the Swedish inpatient registry, researchers found that ... 29 percent in people whose partner had cancer. "Our ...
... is growing rapidly as California,s population ages, but the majority ... have poor access to health care and food, a new ... found. Fifty-seven percent of paid Medi-Cal caregivers ... the state have incomes that leave them in poverty ...
... undergoing treatment for breast cancer can experience cognitive declines, ... and attention. Often experienced by patients undergoing chemotherapy, the ... health psychologist at the University of Missouri says "chemo ... associate professor and chair of the Health Psychology Department ...
... Being nice may be in your genes. That,s according ... least part of the reason why some people are kind ... the University of California, Irvine assessed the behavior of people ... oxytocin and vasopressin -- believed to make people nicer. ...
Cached Medicine News:Health News:AstraZeneca and DNDi to collaborate on drug screening for neglected tropical diseases 2Health News:Drug May Prevent Pancreatitis After Digestive Procedure 2Health News:Majority of California's Medi-Cal caregivers live in or near poverty 2Health News:Majority of California's Medi-Cal caregivers live in or near poverty 3Health News:Stress contributes to cognitive declines in women with breast cancer, researcher says 2Health News: Some Folks Just Can't Help Being Nice, Study Suggests 2
Operate with confidence. Autosuture is advancing the sate of both open and minimally invasive surgery by providing surgical tools that feel right, function right, and facilitate the right outcome eve...
... Many special order products are offered as ... long lengths. The modular instruments may be ... options such as ratchets, insulation and flush ... Mediflex stock. Customer specifications may affect delivery ...
... The 5mm AEM Laparoscopic Instruments incorporate a ... Instruments are shielded and monitored to prevent ... the instrument caused by insulation failure or ... The protective shield built into all AEM ...
... The 5mm AEM Laparoscopic Instruments incorporate a ... Instruments are shielded and monitored to prevent ... the instrument caused by insulation failure or ... The protective shield built into all AEM ...
Medicine Products: