United Therapeutics Corporation (NASDAQ: UTHR) announced today that Medtronic, Inc. (NYSE: MDT) has submitted a pre-market approval application to the U.S. Food and Drug Administration (FDA) for the use of Medtronic's SynchroMed® II implantable drug infusion system (including a newly developed catheter) for use with United Therapeutics' Remodulin® (treprostinil) Injection delivered intravenously to patients with pulmonary arterial hypertension.
United Therapeutics plans to submit to the FDA a supplement to its New Drug Application for Remodulin in January 2015, in order to amend Remodulin's labeling to support the use of the drug with the SynchroMed II implantable drug infusion system.
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