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.

Forward-looking Statements

Statements included in this press release concerning the FDA's pending review of our Tyvaso NDA, the expected duration of such review and our goal of bringing Tyvaso to market are "forward-looking statements" within the meaning of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and current reports on Form 8-K, which could cause actual results to differ materially from anticipated results. We are providing this information as of April 28, 2009, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g]


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

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:2/10/2016)... ... February 10, 2016 , ... ... offering education, research and medical media, has launched Contagion® , a ... diseases. , As the all-inclusive resource for infectious disease information, Contagion features ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... company is unveiling its revolutionary new 2.0 version at the International Roofing Expo ... “put the power of the world's most advanced weather technology in the hands ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... Video Remote Interpreting (VRI) within Healthcare, recently partnered with Heart City Health ... (VRI). , For nearly 23 years, Heart City Health Center has provided the ...
(Date:2/10/2016)... Huntington, NY (PRWEB) , ... February 10, 2016 ... ... web-based compliance tracking solution, The Guard, to associations of medical professionals throughout the ... HIPAA compliance, including security risk assessments, policies and procedures, employee training, regulatory updates, ...
(Date:2/10/2016)... ... 10, 2016 , ... Emergency rooms provide emergency care to stabilize critical health ... patients with dental emergencies at risk of losing a tooth or their smiles. Dr. ... , Common dental emergencies include:, , Avulsed or knocked-out teeth ...
Breaking Medicine News(10 mins):
(Date:2/10/2016)... Calif., Feb. 10, 2016   Genomic Health, Inc. (Nasdaq: ... the quarter and year ended December 31, 2015. ... fourth quarter of 2015, compared with $69.1 million in the fourth ... currency basis, revenue increased 9 percent compared with the same period ... U.S. revenue was $63.9 million in the fourth quarter of ...
(Date:2/10/2016)... 2016 Mylan N.V. (NASDAQ, TASE: MYL) today ... ended December 31, 2015. --> ... total revenues of $9.45 billion, up 28% on a ... revenues of $9.43 billion. Excluding the impact of the ... branded generics business (the "EPD Business"), full year adjusted ...
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
Breaking Medicine Technology: