Biotechnology Business
United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
Published in Medical Letter on the CDC and FDA, April 5th, 2009
United Therapeutics Corporation (NASDAQ:UTHR) announced that, based on its most recent interactions with the U.S. Food and Drug Administration (FDA), the FDA's pending regulatory review of the New Drug Application (NDA) for Tyvaso(TM) (inhaled treprostinil) will likely extend beyond its originally anticipated April 30, 2009, action date. The probable delay relates to questions received from the FDA concerning human factors testing and the instructions for use (IFU) of the OptiNeb(R) portable nebulizer that delivers Tyvaso.
"In response to FDA comments related to our originally submitted instructions for the OptiNeb nebulizer, we provided the FDA with a revised IFU....
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