Treprostinil diolamine extended release tablets (United Therapeutics) re-filed at FDA for treatment of PAH
United Therapeutics Corporation has announced that the FDA has acknowledged the re-submission 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 re-submission as a complete, class 1 response to the FDA Complete Response Letter and set a user fee goal date of March 31, 2013.
Oral treprostinil already is approved in intravenous and subcutaneous formulations, sold as Remodulin, and as an inhalation therapy as Tyvaso.
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