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Remodulin Now Approved for Use With Implantable Pump

August 2, 2018

On July 31, 2018, United Therapeutics announced Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for the use of Remodulin (treprostinil) in the Implantable System for Remodulin (ISR, Medtronic). The drug/device system is indicated for the treatment of pulmonary arterial hypertension (PAH).

In December 2017, the FDA approved a premarket application (PMA) for a proprietary intravascular infusion catheter to be used with Medtronic’s SynchroMed II implantable infusion pump and related infusion system components (together referred to as the ISR), in order to intravenously deliver Remodulin.

FDA approval of the PMA and NDA is based primarily on outcomes of the DelIVery for PAH trial (Bourge et al., 2016).

Remodulin is a prostacyclin vasodilator previously approved by the FDA to treat PAH by continuous subcutaneous and intravenous routes of administration using external pumps.

 

PR Newswire. United Therapeutics Announces FDA Approval Of The Implantable System For Remodulin [news release]. July 31, 2018. Available at: click here. Accessed August 1, 2018.