United Therapeutics Announces FDA Acceptance of Resubmission of Oral
SILVER SPRING, Md., Feb. 14, 2013
SILVER SPRING, Md., Feb. 14, 2013 /PRNewswire/ --United Therapeutics
Corporation(NASDAQ: UTHR) announced today that the U.S. Food and Drug
Administration (FDA) has acknowledged the resubmission of the new drug
application (NDA) for treprostinil diolamine extended release tablets (oral
treprostinil) for the treatment of pulmonary arterial hypertension. The FDA
classified the resubmission as a complete, class 1 response to FDA's October
23, 2012 complete response letter and theFDA set a user fee goal date of
March 31, 2013.
About United Therapeutics
United Therapeutics Corporation is a biotechnology company focused on the
development and commercialization of unique medicinal products.
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 the FDA's user fee goal date of March 31, 2013.
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
Form10-K, Quarterly Reports on Form10-Q, and Current Reports on Form8-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 February14, 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
Contact: Andrew Fisher, +1-202-483-7000, Afisher@unither.com
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