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:12/4/2016)... ... ... James Earl Jones is known for myriad roles on stage and screen, he has ... the forthcoming episodes examines mammogram techniques; a very important part of preventative medicine. , ... detection. Like any other disease, treatments have a much higher chance of success if ...
(Date:12/4/2016)... CA (PRWEB) , ... December 04, 2016 , ... ... without undergoing major cosmetic surgery can now take advantage of a cosmetic procedure ... advanced skin rejuvenation treatment that reduces the appearance of age spots, fine ...
(Date:12/2/2016)... ... ... Lori G. Cohen and Sara K. Thompson , shareholders ... American Conference Institute’s 21st Drug & Medical Device Litigation Conference , taking place in ... , Cohen, who chairs the firm’s Pharmaceutical, Medical Device & Health Care Litigation Practice ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ... across the Dothan-Wiregrass Area in Alabama are expected to attend the UNCF Dothan-Wiregrass ... will help provide scholarship funds for area students and operating support to UNCF-member ...
(Date:12/2/2016)... ... December 02, 2016 , ... The annual time frame ... (or Annual Election Period), is ending December 7th. Currently-enrolled Medicare beneficiaries who are looking ... prescription drug plan (Part D) need to make changes during this period order for ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... , December 2, 2016 bioLytical Laboratories, ein Weltführer ... bei den Mitgliedern des Apothekenbundes von Kenia eingeführt. ... ... INSTI HIV Self Test! (PRNewsFoto/bioLytical Laboratories) ...      (Photo: http://photos.prnewswire.com/prnh/20161201/444905 ) ...
(Date:12/2/2016)... , Dec. 2, 2016 Boston Scientific Corporation ... agreement to acquire certain manufacturing assets and capabilities of ... NVC) advanced biological tissue business, as well as a ... $75 million in cash. The Neovasc advanced biological tissue ... the Boston Scientific Lotus™ Valve System. * Upon ...
(Date:12/2/2016)... 2016 Lianluo Smart Limited (Nasdaq: ... which develops, markets and sells medical devices and ... and international markets, recently attended the ... New Progress Forum, co-hosted by the Institute of ... , Guangdong Provincial People,s Hospital and Cardiology Department ...
Breaking Medicine Technology: