Navigation Links
U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months
Date:4/28/2009

SILVER SPRING, Md., April 28 /PRNewswire-FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR) announced today that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Tyvaso(TM) (inhaled treprostinil). In a notice received today, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from April 30, 2009, to July 30, 2009. United Therapeutics previously disclosed the likelihood of this delay in a press release dated March 16, 2009.

The three-month extension was triggered by United Therapeutics' April 2009 submission to the FDA of the results of a human factors study, which was considered a major amendment to the NDA. In March 2009, the FDA notified United Therapeutics that it required human factors testing to validate the instructions for use of the Optineb(R) nebulizer in order to complete its evaluation of the Tyvaso NDA. "We look forward to working with the FDA as it completes its review of our human factors study submission," said Roger Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer. "We made every effort to conduct and submit the study as quickly as possible."

"We are most appreciative of the FDA's input as we work toward our goal of bringing Tyvaso to market," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and Chief Executive Officer. "This news will provide considerable hope to the thousands of pulmonary hypertension patients struggling with existing treatments."

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.

'/>"/>
SOURCE United Therapeutics Corporation
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related medicine news :

1. VNUS Medical Technologies Announces Resignation of Chief Financial Officer and VP, Finance & Administration
2. Office of Administration Announces Plan to Preserve Health Care Benefits for Current, Future Retired Commonwealth Employees
3. Wells Fargo Offers Online Benefit Administration for Business and Individual Healthcare Consumers
4. Administration Anesthetized to Ailments of Nations Children
5. Supratek Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for SP1049C for the treatment of metastatic adenocarcinoma of the upper gastrointestinal tract
6. Siemens Medical Solutions Receives CCHIT Certification for Soarian Clinicals With Siemens Pharmacy and Med Administration Check
7. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for Adolescent Patients With Schizophrenia
8. Abbott Receives U.S. Food and Drug Administration Approval for New Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients
9. Chip PC Wins Europes Largest Thin Client Tender to Supply 20,000 Thin Clients and Management Software to German RZF - Financial Administration of North Rhine-Westphalia County
10. ActiPatch(TM) Granted Market Clearance by the Food & Drug Administration in the Kingdom of Jordan
11. ABILIFY(R) (aripiprazole) Supplemental New Drug Application for the Treatment of Pediatric Patients with Bipolar I Disorder Accepted for Priority Review by the U.S. Food and Drug Administration
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2014)... 2014 Robins & Morton received ... Builders and Contractors (ABC) of Alabama. , ABC ... held at Sheraton Birmingham Hotel., , ... Million to $25 Million, Obelisk Award (First Place) ... Government $10 Million to $25 Million, Obelisk Award ...
(Date:10/2/2014)... Australia (PRWEB) October 02, 2014 ... markets, organic food is becoming increasingly popular with ... Organic Livestock and Poultry Farming industry in ... “the popularity of organic meat has surged over ... and expansion at the farming level.” Over the ...
(Date:10/2/2014)... HealthDay Reporter WEDNESDAY, Oct. 1, 2014 (HealthDay ... long-acting implanted devices -- could slash pregnancy and abortion rates ... In a study of 1,400 teenage girls, researchers found ... of unplanned pregnancy and abortion. Over three years, their annual ... rate of 158 per 1,000 among all sexually active teenage ...
(Date:10/2/2014)... have pinpointed a molecule that may trigger potentially life-threatening ... say this finding could offer a target for new ... Most asthma attacks (80 percent to 90 percent) are ... the British researchers. Most of these are rhinoviruses, which ... The researchers found that a specific molecule called IL-25 ...
(Date:10/2/2014)... WEDNESDAY, Oct. 1, 2014 (HealthDay News) -- Children with ... but they,re fully capable of being more active, a ... activity levels of 29 children, some with autism and ... per day of moderate physical activity and 70 more ... The 17 children with autism scored lower on strength, ...
Breaking Medicine News(10 mins):Health News:Robins & Morton wins nine awards from Associated Builders and Contractors 2Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 2Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 3Health News:Organic Livestock and Poultry Farming in Australia Industry Market Research Report Now Available from IBISWorld 4Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 2Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 3Health News:Free, Long-Acting Contraceptives May Greatly Reduce Teen Pregnancy Rate 4Health News:New Clues to How Colds Can Spur Asthma Attacks 2Health News:Kids With Autism Tend to Be Less Active, Study Says 2
... hospitals throughout Indiana are now connected ... Physicians and patients at the Howard Regional Health ... from the clinical information exchanged through Indiana Health ... health care providers have implemented IHIE,s secure, Web-based ...
... Frost & Sullivan presented 20 awards ... sector at the 2009 Frost & Sullivan ... today at the InterContinental hotel in Singapore. (Logo: ... the awards banquet recognised companies across pharmaceuticals, clinical ...
... turning to a new trend to let others ... A case report will be presented Friday, May ... (AACE) 18th Annual Meeting & Clinical Congress shedding ... from the medical community. (Logo: http://www.newscom.com/cgi-bin/prnh/20090324/DC88061LOGO-b ...
... for Leadership Vision and Achievements in Advancing Health ... The Workgroup for Electronic Data Interchange is honoring ... Halvorson, with the 2009 Louis Sullivan Award. ... through their leadership vision and achievements in advancing ...
... in Mid-Atlantic RegionDENVER, April 21 Global ... "Company") (OTC Bulletin Board: GLOB), an international ... its Wyndgate Technologies(R) division has licensed its ... Donor Doc(TM) electronic donor history questionnaire to ...
... Care Brand Gains Another Top RecognitionFORT WORTH, Texas, ... moisturizers, currently the #1 Dermatologist Recommended brand of ... pediatricians. Cetaphil(R) products are specially formulated to provide ... look and feel its best, and the brand ...
Cached Medicine News:Health News:Kokomo Hospitals Implement Indiana Health Information Exchange Clinical Messaging Service 2Health News:Kokomo Hospitals Implement Indiana Health Information Exchange Clinical Messaging Service 3Health News:Outstanding Healthcare Companies in Asia Pacific Honored 2Health News:Outstanding Healthcare Companies in Asia Pacific Honored 3Health News:Outstanding Healthcare Companies in Asia Pacific Honored 4Health News:Outstanding Healthcare Companies in Asia Pacific Honored 5Health News:New Research Reveals Need for Doctors to Know About Medical Tattoos 2Health News:Kaiser Permanente CEO George Halvorson Receives National Award From the Workgroup for Electronic Data Interchange 2Health News:Kaiser Permanente CEO George Halvorson Receives National Award From the Workgroup for Electronic Data Interchange 3Health News:Global Med Technologies(R) Licenses ElDorado(TM) Software Solutions to $3.5 Billion MedStar Health of Baltimore, MD 2Health News:Global Med Technologies(R) Licenses ElDorado(TM) Software Solutions to $3.5 Billion MedStar Health of Baltimore, MD 3Health News:Global Med Technologies(R) Licenses ElDorado(TM) Software Solutions to $3.5 Billion MedStar Health of Baltimore, MD 4Health News:Cetaphil(R) Cleansers and Moisturizers Now the #1 Pediatrician Recommended Brand 2
(Date:10/2/2014)... 2, 2014  MinuteClinic, the largest and fastest growing provider of ... has opened its first walk-in clinics in the Corpus ... Corpus Christi and Portland . ... in December. The clinics are part of MinuteClinic,s ... With the Corpus Christi -area openings, there are ...
(Date:10/2/2014)... 2, 2014   Mast Therapeutics, Inc. (NYSE ... Edwin L. Parsley , D.O. has joined the ... President.  Dr. Parsley has been actively engaged ... in February 2014.  He has served as Mast,s interim ... Medical Officer of Aires since April 2011.  Dr. Parsley ...
(Date:10/1/2014)... CITY, Calif. , Oct. 1, 2014  Abaxis, ... company manufacturing point-of-care instruments and consumables for the medical, ... services to the veterinary and research markets in ... has entered into a definitive distribution agreement with Patterson ... market and promote the full line of Abaxis veterinary ...
Breaking Medicine Technology:First MinuteClinic Walk-in Medical Clinics Open in Corpus Christi 2First MinuteClinic Walk-in Medical Clinics Open in Corpus Christi 3Mast Therapeutics Announces Appointment Of Chief Medical Officer 2Mast Therapeutics Announces Appointment Of Chief Medical Officer 3Mast Therapeutics Announces Appointment Of Chief Medical Officer 4Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 2Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 3Abaxis Announces Distribution Agreement with Patterson Veterinary Supply 4
... /PRNewswire-Asia/ -- Chindex International, Inc. (Nasdaq: CHDX ... providing health care services in China through the operations ... primary care hospitals and affiliated ambulatory clinics, today announced ... ended December 31, 2010. Presentation of ...
... American Association for Homecare strongly endorses bipartisan legislation to ... program for home medical equipment and services (durable medical ... Glenn Thompson (R-Pa.) and Jason Altmire (D-Pa.) on March ... Bidding Act."   Tyler Wilson, president ...
Cached Medicine Technology:Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 2Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 3Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 4Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 5Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 6Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 7Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 8Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 9Chindex International, Inc. Reports Financial Results for the Three and Nine Month Period Ended December 31, 2010 10Home Medical Equipment Group Supports Bipartisan Bill to Repeal the Controversial Medicare 'Competitive' Bidding Program for Homecare 2Home Medical Equipment Group Supports Bipartisan Bill to Repeal the Controversial Medicare 'Competitive' Bidding Program for Homecare 3