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

PHILADELPHIA, Sept. 22, 2011 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces an update on the approval status and availability of ProAmatine® (midodrine HCl), a medicine approved for the treatment of symptomatic orthostatic hypotension (SOH).  Shire has engaged in consistent dialogue with the U.S. Food and Drug Administration (FDA) for the past 12 months in the hopes of either securing final FDA approval of this medicine based on the data submitted following two post-marketing clinical trials, or establishing an agreed development plan for conducting additional clinical trials.

ProAmatine remains available to patients today as discussions between FDA and Shire continue concerning the status of its NDA.  Shire, the NDA holder for ProAmatine, remains committed to ensuring midodrine remains available for patients who critically need this medicine and who would be left without alternative treatments should it be withdrawn from the market."While we continue to work with the FDA to design trials that further confirm the clinical efficacy of ProAmatine, we've reached an impasse and we now believe the fastest way to get the final approval for this medicine is to present our data at a public hearing, thereby sparing patients the additional hardships of clinical trials," said Jeffrey Jonas, M.D., Senior Vice President of Research & Development for Shire.  "This is a unique situation and we're doing everything we can to keep this medicine on the market so patients can continue to access it."

ProAmatine was approved in 1996 under Subpart H (an accelerated approval process) for the treatment of SOH, with a post-approval commitment to conduct two clinical trials to verify the clinical effect of midodrine.  The initial approval was based on ProAmatine's demonstrated ability to significantly
'/>"/>

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:7/11/2014)... HILL, N.C. , July 11, 2014 /PRNewswire/ ... analysis approaches are evolving across industry sectors to ... now examining better ways to engage with and ... consumers inform themselves and make critical purchasing decisions. ... benchmarking firm, Best Practices, LLC, one area where ...
(Date:7/11/2014)... -- Research and Markets  has announced the addition ... report to their offering. ... hollow needle commonly used with a syringe to inject ... from it. A hypodermic needle is used for rapid ... be ingested. Hypodermic needles are broadly classified into non-safety ...
(Date:7/11/2014)... ALBANY, New York , July 11, 2014 /PRNewswire/ ... published by Transparency Market Research "Endoscopy Devices Market (Endoscopes, ... Analysis, Size, Share, Growth, Trends and Forecast, 2013-2019" the ... billion in 2012 and is expected to grow at ... reach an estimated value of USD 36.9 billion in ...
Breaking Medicine Technology:New Technologies Transforming Consumer Marketing Research Playbook 2Global Hypodermic Needles Market 2014-2018: Key Vendors are Becton, Dickinson and Co, Covidien, Retractable Technologies and Terumo Corp. 2Global Hypodermic Needles Market 2014-2018: Key Vendors are Becton, Dickinson and Co, Covidien, Retractable Technologies and Terumo Corp. 3Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 2Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 3Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 4Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 5Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 6
(Date:7/12/2014)... Wright & Schulte LLC has filed a DePuy Pinnacle ... Johnson & Johnson, on behalf of an Ohio man who ... DePuy Pinnacle hip replacement and had to undergo revision surgery ... DePuy hip lawsuit was filed July 7, 2014, in the ... where DePuy Pinnacle Hip lawsuit litigation is underway . ...
(Date:7/12/2014)... New York, NY (PRWEB) July 12, 2014 ... (the National Institute of Standards and Technology), the June ... up the electronic discovery world. It was ... was finally in, depending on whether it was seen from ... But this much is fact, there is now precedent ...
(Date:7/12/2014)... article released by Seattle's well known plastic surgeon, Dr. Bryan ... cosmetic surgical procedures in summer months . , As ... enliven the rainy Pacific Northwest, many people are turning their ... out as much during the winter as they had planned. ... eager to look their best for their summer vacations, and ...
(Date:7/12/2014)... Restore My Vision Today is a ... a couple boasting very impressive credentials on the field ... Today as a way to help consumers do without ... their respective patients’ treatments . , In ... trove of pertinent information relevant to eye care like:, ...
(Date:7/12/2014)... The largest pure occupational medicine company in the ... it will be opening its fifth Georgia center in ... Atlanta-based Nova Medical Centers’ locations. The Augusta facility ... and will be open from 8:30 a.m. to 6 ... philosophy of rapid return-to-work and decreased treatment times for ...
Breaking Medicine News(10 mins):Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 2Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 3Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 4Health News:DePuy Pinnacle Hip Lawsuit Filed By Wright & Schulte LLC On Behalf of Ohio Man Who Required Revision Surgery Purportedly From Defective Hip Implant 5Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 2Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 3Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 4Health News:Mobile Device Forensics Guidelines Play Key Role in Supreme Court’s Smartphone Evidence Warrant Decision 5Health News:Best Summer Cosmetic Surgeries Revealed in Article By Seattle Plastic Surgeon 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 2Health News:Restore My Vision Today | Groundbreaking Book Reveals How To Restore Your Vision Without The Use of Glasses – Vinamy 3Health News:Nova Medical Centers To Open New Facility in Augusta, Georgia 2
... Students to Get Fit By Finals, , Awards School with ... Chicago Bulls legend BJ Armstrong is rallying Chicago ... new national campaign called Get Fit By Finals . ... "got milk?" Body By Milk(R) Campaign and NBA FIT, the NBA,s ...
... galectin-3 may serve as treatment target against disease ... -- A newly identified marker for prostate cancer ... treatment, University of Michigan researchers say. , Previous ... marker galectin-3 are linked with neoplastic progression in ...
... Will Earn Decision Resources, Clinical Gold Standard Status ... a New Report from Decision ResourcesWALTHAM, Mass., March ... leading research and advisory firms for pharmaceutical and ... a therapy,s effect on the rate of mortality ...
... 2008 Frost & Sullivan European Human Growth ... to Ferring Pharmaceuticals. The award is in ... injection for human growth hormone (hGH). The ... VISION X, innovative no-needle delivery systems for ...
... WELLINGTON, Fla., March 25 The Quantum Group, Inc. ... announced it has implemented a reallocation of ... the PWeR(TM) (pronounced POWER) platform. As Quantum continues ... the Company expects for the PWeR platform, it has ...
... Osteoarthritis Sufferers to Live Fit by Thinking Fit, Eating ... 25 Today, Bob Greene, best-selling author and personal ... the 27 million Americans who suffer from osteoarthritis (OA) ... Pharmaceuticals (Nasdaq: ENDP ), the MOVE (Managing ...
Cached Medicine News:Health News:Got Milk?(R) and the NBA Showcase New National Teen Health and Fitness Initiative at Cesar E. Chavez Multicultural Center 2Health News:Got Milk?(R) and the NBA Showcase New National Teen Health and Fitness Initiative at Cesar E. Chavez Multicultural Center 3Health News:Got Milk?(R) and the NBA Showcase New National Teen Health and Fitness Initiative at Cesar E. Chavez Multicultural Center 4Health News:Got Milk?(R) and the NBA Showcase New National Teen Health and Fitness Initiative at Cesar E. Chavez Multicultural Center 5Health News:Surveyed Experts Indicate that Biogen Idec's Adentri Has Advantages Over Nitroglycerin in the Treatment of Acute Heart Failure 2Health News:Surveyed Experts Indicate that Biogen Idec's Adentri Has Advantages Over Nitroglycerin in the Treatment of Acute Heart Failure 3Health News:Frost & Sullivan Accolade for Ferring Pharmaceuticals 2Health News:Frost & Sullivan Accolade for Ferring Pharmaceuticals 3Health News:The Quantum Group Announces Resource Reallocation to Advance PWeR(TM) Platform 2Health News:The Quantum Group Announces Resource Reallocation to Advance PWeR(TM) Platform 3Health News:The Quantum Group Announces Resource Reallocation to Advance PWeR(TM) Platform 4Health News:The Quantum Group Announces Resource Reallocation to Advance PWeR(TM) Platform 5Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 2Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 3Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 4Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 5Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 6Health News:Exercise Physiologist and Celebrity Trainer Bob Greene Leads National Campaign to Showcase Osteoarthritis Pain Management Techniques and New Treatment Approaches 7
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: