Navigation Links
United Therapeutics Announces Receipt Of Second Complete Response Letter For Oral Treprostinil NDA
Date:3/25/2013

SILVER SPRING, Md., March 25, 2013 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a second complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

Martine Rothblatt , Ph.D., Chairman and Chief Executive Officer of United Therapeutics commented, "We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner."

United Therapeutics intends to immediately request an "end of review" meeting with the FDA to discuss this complete response letter.

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 conditions.

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, among others, statements regarding United Therapeutics' future efforts to gain approval of oral treprostinil, the related timing of those efforts, and actions United Therapeutics may take in response to the FDA's complete response letter.   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, that could cause actual results to differ materially from anticipated results. Consequently, such 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. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of March 25, 2013, 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©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. DDS Lab Announces Strategic Alliance with United Concordia
2. United Spinals UsersFirst Mobilizes Wheelchair Users to Demand Access to Essential Mobility Equipment
3. United Therapeutics Corporation Reports 2012 Fourth Quarter and Annual Financial Results
4. United Therapeutics Announces FDA Acceptance of Resubmission of Oral Treprostinil NDA
5. United BioSource Corp. erweitert mit entscheidender Neubesetzung Potenzial in Europa
6. United BioSource Corp. expande sus capacidades europeas con contrataciones clave
7. United Kingdom Ophthalmic Devices Market Outlook to 2018 - Vision Care, Intraocular Lens (IOL), Cataract Surgery Devices, Ophthalmic Diagnostic Equipment, Refractive Surgery Devices, Vitreo Retinal Surgery Devices and Others
8. United States Ophthalmic Devices Market Outlook to 2018 - Vision Care, Intraocular Lens (IOL), Cataract Surgery Devices, Ophthalmic Diagnostic Equipment, Refractive Surgery Devices, Vitreo Retinal Surgery Devices and Others
9. Kevin Johnson Joins United Allergy Services Board Of Directors
10. The Treatment Landscape for Hepatocellular Carcinoma Will Change Dramatically Over the Next Ten Years Due to the Launch of New Therapies in the United States and EU5
11. Oncologists in the United States and Europe Indicate that Novel Chemotherapies Hold the Most Near-Term Promise for Improving Outcomes in Soft Tissue Sarcoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/17/2017)... August 17, 2017 DarioHealth Corp. (NASDAQ: ... mobile health and big data solutions, announced today ... domestic and non-U.S. investors for the sale of ... of the Company,s newly designated Series B Convertible ... Company expects to conduct a closing with respect ...
(Date:8/15/2017)... WILMINGTON, N.C. , Aug. 15, 2017 ... Wilmington, NC , today announced that the company ... at the University of North Carolina at Chapel Hill ... AccuKit-HIV is designed to characterize and quantify HIV reservoir ... and after pharmacological intervention. The HIV Cure Center is ...
(Date:8/8/2017)... Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on ... the second quarter ended June 30, 2017. ... to date: Continued ... lead project, BL-8040: Announced plans to ... stem cell mobilization treatment for autologous bone-marrow transplantation in ...
Breaking Medicine Technology:
(Date:8/20/2017)... , ... August 20, 2017 , ... Are you an ... household? If so, you may be interested in participating in a research study ... this research is to understand more about the relational aspects of adults who have ...
(Date:8/19/2017)... ... August 18, 2017 , ... President Donald Trump ... legislation that provides for greater public access to over-the-counter (OTC) hearing aids. , ... OTC hearing aids without being seen by a certified and licensed audiologist. ...
(Date:8/19/2017)... CA (PRWEB) , ... August 19, 2017 , ... Yesterday, ... the KKK by saying there are two sides. There are not two sides to ... way to rationalize violence and prejudice, and the NPEIV stands against all forms of ...
(Date:8/18/2017)... (PRWEB) , ... August 19, 2017 , ... ... Tourism Authority of Thailand presided over the Amazing Thailand Health and Wellness Tourism ... Thailand. , Mr. Noppadon Pakprot, Deputy Governor for Tourism Products and Business at ...
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet ... advocating for active, healthy lifestyles and highlighting the importance of proactive eye and ... impairments and shares the latest innovations in hearing aid technology. , In ...
Breaking Medicine News(10 mins):