Navigation Links
United Therapeutics Announces Receipt Of Second Complete Response Letter For Oral Treprostinil NDA

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:
(Date:6/24/2016)... Belgium , June 24, 2016 /PRNewswire/ ... announced the appointment of Dr. Edward Futcher ... a Non-Executive Director, effective June 23, 2016.Dr. Futcher ... and Nominations and Governance Committees.  As a non-executive ... provide independent expertise and strategic counsel to VolitionRx ...
(Date:6/23/2016)... Research and Markets has announced ... Type (Organic Chemical (Sugar, Petrochemical, Glycerin), Inorganic Chemical), Functionality ... - Global Forecast to 2021" report to their ... global pharmaceutical excipients market is projected to reach USD ... in the forecast period 2016 to 2021. ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department ... in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at ... Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 ...
(Date:6/24/2016)... CA (PRWEB) , ... June 24, 2016 , ... A ... procedures that most people are unfamiliar with. The article goes on to state that ... but also many of these less common operations such as calf and cheek reduction. ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... June 19, ... the dangers associated with chronic pain and the benefits of holistic treatments, Serenity ... who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) is a ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... San Francisco, CA (PRWEB) , ... June 24, ... ... at CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has ... , self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , ...
Breaking Medicine News(10 mins):