Oral Treprostinil New Drug Application Accepted by FDA for Review
SILVER SPRING, Md., Feb. 21, 2012 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that the U.S. Food and Drug Administration has accepted for review the new drug application (NDA) for treprostinil diethanolamine sustained release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension. The NDA will be subjected to a standard 10-month review period, with a targeted user fee deadline of October 27, 2012.
About United Therapeutics
United Therapeutics 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. [uthr-g]
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, our expectation that the oral treprostinil NDA will be subject to a standard 10-month review period with a targeted user fee deadline of October 27, 2012. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic and other reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. 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 February 21, 2012, 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.
SOURCE United Therapeutics Corporation