Correvio Pharma Corp. Highlights FDA Acceptance of United Therapeutics' Trevyent New Drug Application
September 12, 2019 at 10:36 pm IST
Correvio Pharma Corp. highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation's New Drug Application (NDA) for Trevyent (treprostinil) for the treatment of pulmonary arterial hypertension (PAH). The FDA assigned the NDA a Prescription Drug User Fee Act (PDUFA) target action date of April 27, 2020. Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of PAH. Correvio holds commercial rights to Trevyent for the international markets of Europe and the Middle East and expects to file regulatory submissions for Trevyent in Europe in mid-2020.