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News Breaks
February 14, 2013
06:09 EDTUTHRUnited Therapeutics reports FDA acceptance of oral Treprostinil NDA reacceptance
United Therapeutics announced that the U.S. Food and Drug Administration has acknowledged the resubmission of the new drug application for treprostinil diolamine extended release tablets 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 the FDA set a user fee goal date of March 31, 2013.
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August 19, 2015
06:09 EDTUTHRUnited Therapeutics agrees to sell PPRV to AbbVie for $350M
United Therapeutics (UTHR) announced that it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher, or PPRV, to a subsidiary of AbbVie (ABBV). United Therapeutics received the PPRV when Unituxin was approved by the FDA for the treatment of neuroblastoma, a rare pediatric disease. Upon closing of the transaction, United Therapeutics will receive $350M in cash in exchange for the PPRV. The voucher was awarded by the FDA under a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases.
August 17, 2015
06:04 EDTUTHRUnited Therapeutics reports EC Marketing Authorisation for Unituxin
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