FDA accepts NDA for oral Remodulin (United Therapeutics) for PAH - 22-Feb-2012
The FDA has accepted for review the new drug application (NDA) for oral Remodulin (treprostinil diethanolamine sustained release), from United Therapeutics, 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.
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