Navigation Links
New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
Date:6/30/2008

n vasodilatory side effects of prostacyclin and its analogs (e.g., headache, nausea, dizziness, flushing) and those commonly associated with the inhalation route of administration (e.g., cough and throat irritation). These side effects were mostly mild or moderate in severity and were not dose-limiting in the majority of patients treated with ITRE.

About United Therapeutics

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.

About Lung Rx

Lung Rx is a biotechnology company focused on unmet medical needs in pulmonary medicine and pulmonary delivery of innovative therapeutic products.

Forward-looking Statements

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include our expectation that the ITRE NDA will be subject to a 10- to 12-month review period and our belief that ITRE will be a desirable option for PAH patients once it has been approved for marketing. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, which could cause actual results to differ materially from anticipated results. These risks and uncertainties include, among others, the failure of ITRE and the nebulizers used to administer ITRE to receive regulatory approvals on the schedule expected; the uncertainties of launching a new product on a global scale following receipt of regulatory approvals, if received, due to misestimates of the time and resources required to do so, or for other reasons; the failure of ITRE to receive favorable pricing or reimbursement; the possible
'/>"/>

SOURCE United Therapeutics Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. FDA Files Application To Convert ONTAK(R) (Denileukin Diftitox) to Full Approval for Use in Cutaneous T-Cell Lymphoma (CTCL)
2. Vermillion Files 510(k) Application With U.S. Food & Drug Administration for OVA1 Ovarian Tumor Triage Test
3. Synapse Biomedical Receives FDA Approval of NeuRx Diaphragm Pacing System (DPS)(TM) For Spinal Cord Injury Breathing Applications
4. Transcept Pharmaceuticals Announces Intent to Submit New Drug Application for Intermezzo(R) in Third Quarter 2008
5. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
6. Lilly Submits Cymbalta(R) Supplemental New Drug Application for Chronic Pain to U.S. Food and Drug Administration
7. GlaxoSmithKline Announces New Drug Application and Phase III Results for Rezonic(TM)/Zunrisa(TM) (Casopitant)
8. Community Breast Center Experience Shows Real-World Application of Breast-Specific Gamma Imaging Has Significant Impact on Clinical Care
9. European Regulatory Agency Accepts Cell Therapeutics, Inc.s Marketing Authorization Application for XYOTAX(TM) for Lung Cancer for Review
10. FDA Accepts Investigational New Drug Application for ARI-2243 and a First in Man Clinical Trial Set to Begin During the First Half of 2008
11. Cell Therapeutics, Inc. (CTI) Submits European Marketing Authorization Application for XYOTAX(TM)

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/20/2009)..., , MINNEAPOLIS, Nov. 20 /PRNewswire-FirstC...ounced results for its first quarter ended Septemb...4 per diluted share, on revenues of $3,263,000. T... per diluted share, on revenues of $3,168,000 for ...n the first quarter results, Biotel President and ...
(Date:11/20/2009)..., , PLYMOUTH MEETING, Pa., Nov. 20 /PRN...w York Times article that questions why currently...nt some cancers are being ignored, ECRI Institute,...g a roadmap to the evidence on Finasteride for Pr...,, The November 13, 2009, New York Times arti...
(Date:11/20/2009)..., , MEMPHIS, Tenn., Nov. 20 /PRNewswire-F...thopaedics Division is pleased to announce the sig... United States Department of Defense that may lead...ended to revolutionize the treatment of the limbs ..., Last year, the Defense Advanced Research Project...
Breaking Medicine Technology:Biotel Announced Profitable First Quarter Ended September 30, 2009 2ECRI Institute Releases Roadmap to the Evidence on Finasteride for Prevention of Prostate Cancer: New Hotline Report to Aid Healthcare Decision Makers and Journalists 2ECRI Institute Releases Roadmap to the Evidence on Finasteride for Prevention of Prostate Cancer: New Hotline Report to Aid Healthcare Decision Makers and Journalists 3Smith & Nephew Orthopaedics Selected to Develop New Technology for Treating Battlefield Injuries 2Smith & Nephew Orthopaedics Selected to Develop New Technology for Treating Battlefield Injuries 3Smith & Nephew Orthopaedics Selected to Develop New Technology for Treating Battlefield Injuries 4New Fertility Financing for Donated Eggs Fills Void Left by Capital One 51716 1New Fertility Financing for Donated Eggs Fills Void Left by Capital One 51716 2Educated Parkinsons Patients Move to Meds Sooner 51713 1Educated Parkinsons Patients Move to Meds Sooner 51713 2Exponent to Announce Second Quarter 2009 Results 51709 1
...preclinical data presented by Dr. Peter Jones, Dir...cer Center, SAN FRANCISCO, Oct. 25 SuperGen Inc....d to the discovery, rapid,development and commerci...logical malignancies, today announced as part of a...C International Conference that,S110, the Company,...
...y Published in Neurogastroenterology and Motility-...Inc. (AMEX: SYI ) announced today the publication...its compound, alagebrium, to,reduce serum levels o...e,neuronal nitric oxide synthase (nNOS) activity i...S activity is one of the major putative mechanisms...
Other Medicine Technology:SuperGen's Novel Hypomethylating Agent Highlighted at AACR Plenary Session 2SuperGen's Novel Hypomethylating Agent Highlighted at AACR Plenary Session 3Synvista Therapeutics' Alagebrium Shows Potential for use in Treating Diabetes-Related Gastrointestinal Complications 2Synvista Therapeutics' Alagebrium Shows Potential for use in Treating Diabetes-Related Gastrointestinal Complications 3Synvista Therapeutics' Alagebrium Shows Potential for use in Treating Diabetes-Related Gastrointestinal Complications 4
(Date:11/20/2009)...K, Nov. 20 SIRIUS XM Ra... broadcast Doctor Radio Reports: What Every Wom...ecial hosted by veteran journalist Perri Peltz. ,...0080819/NYTU044LOGO ) ,, Doctor Radio Report... will air November 21 live at 10:00 am ET on Do...
(Date:11/20/2009)...osure to formaldehyde used for embalming in the fu...isk of death from myeloid leukemia, according to a...urnal of the National Cancer Institute . , Previ...ohematopoietic malignancies and brain cancer in an...rs, all of whom may have worked with formaldehyde....
(Date:11/20/2009)... November 20, 2009Emergency medical service (EMS) ... 350,000 cardiac arrests each year. Only 5 to 10 ...urvive. Better quality cardiopulmonary resuscitat...y be associated with better patient outcome. The ...gest clinical research network to study prehospita...
(Date:11/20/2009)...hort as 34 weeks, potentially adding to preemie de.... 20 (HealthDay News) -- Recent reports show that ...in the United States. Now, a new study suggests o...constitutes a full-term birth in the first place. ...the study considered a baby born at 34 to 36 weeks...
(Date:11/20/2009)...re severe cases than with seasonal flu , ...esearchers are reporting that children with asthma...lu than seasonal flu. , "Asthma has been identi...th pandemic H1N1 influenza, present in 21 percent ...ton Allen and fellow researchers from the Hospital...
Breaking Medicine News(10 mins):Health News:SIRIUS XM to Broadcast 'Doctor Radio Reports: What Every Woman Needs To Know About Mammograms' 2Health News:SIRIUS XM to Broadcast 'Doctor Radio Reports: What Every Woman Needs To Know About Mammograms' 3Health News:SIRIUS XM to Broadcast 'Doctor Radio Reports: What Every Woman Needs To Know About Mammograms' 4Health News:SIRIUS XM to Broadcast 'Doctor Radio Reports: What Every Woman Needs To Know About Mammograms' 5Health News:Funeral industry workers exposed to formaldehyde face higher risk of leukemia 2Health News:Effect of real-time CPR feedback reported at resuscitation science symposium 2Health News:Effect of real-time CPR feedback reported at resuscitation science symposium 3Health News:Many Women Miscalculate Time to Full-Term Birth 2Health News:Many Women Miscalculate Time to Full-Term Birth 3Health News:Many Women Miscalculate Time to Full-Term Birth 4
..., Ga., May 18 GeckoSystems Intl. Corp. (Pink Shee...personal robot sales forecasts for the years 2010 ...emerging Mobile Service Robot (MSR) industry revol...ompany. At the time of our founding, nearly twelve...
...ach County,s top-rated, highly trained and license...zed home healthcare services for seniors - 24 hour... 18 The healthcare team at Allegiance Home He...eryone,s needs are different and they customize tr...
... New Public Health Resource Cente...lic health opportunities before they enroll in sch...y 18, 2009 -- All Allied Health Schools announces ...ight decisions for their education and careers. Th...
...ogramming can occur in just 3 days time , ...luted air for even a short period of time can caus...ffect a person,s risk of developing cancer and oth...s at a foundry near Milan revealed that after only...
...09, SAN DIEGOA large, well-controlled, multi-natio...fectiveness and safety of what may become the firs...ibrosis, or IPF., In a Phase III clinical study p...of lung capacity in patients suffering from IPF. ...
...e in Forced Vital Capacity is among strongest pred... 17 InterMune, Inc. (Nasdaq: ITMN ) today repor...ship between various measures of clinical status a... Society (ATS) in San Diego. , , The study demo...
Other Medicine News:Health News:GeckoSystems Reveals Eldercare Capable Personal Robot Sales Forecasts 2Health News:GeckoSystems Reveals Eldercare Capable Personal Robot Sales Forecasts 3Health News:Allegiance Home Health and Rehab Selects TransMedia Group as Their Public Relations Firm of Record 2Health News:All Allied Health Schools Provides Public Health Students with Career and Education Resources 2Health News:All Allied Health Schools Provides Public Health Students with Career and Education Resources 3Health News:Short-Term Air Pollution Exposure May Damage DNA 2Health News:Large clinical trial finds pirfenidone may help lung function in IPF patients 2Health News:Large clinical trial finds pirfenidone may help lung function in IPF patients 3Health News:Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis 2Health News:Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis 3Health News:Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis 4Health News:Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis 5Health News:Important Data Presented on Independent Predictors of Mortality in Patients With Idiopathic Pulmonary Fibrosis 6
...rews with NeedlePunch Needles are ideal for arthro...ment. The NeedlePunch Needles are preloaded on one...haft. As the anchor is being inserted, ensure the ...ng the handle to ensure suture slide ability for e...
FiberWire® Suture Kit
FiberSnare™
Flowstar Uroflowmeter
Medicine Products: