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Trevyent FDA Approval Status

Last updated by Judith Stewart, BPharm on May 2, 2020.

FDA Approved: No
Brand name: Trevyent
Generic name: treprostinil
Company: United Therapeutics Corporation
Treatment for: Pulmonary Arterial Hypertension

Trevyent (treprostinil) is a preservative-free, parenteral formulation of the approved vasodilatory prostacyclin analogue treprostinil delivered via the proprietary PatchPump infusion system for the treatment of pulmonary arterial hypertension (PAH).

Development timeline for Trevyent

Sep 11, 2019United Therapeutics Announces FDA Acceptance of Trevyent New Drug Application For Review
Dec  8, 2017SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
Aug 31, 2017SteadyMed Receives Refusal to File Letter from FDA for Trevyent New Drug Application
Jun 30, 2017Steadymed Submits New Drug Application for Trevyent

Further information

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