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Trevyent Approval Status

FDA Approved: No
Brand name: Trevyent
Generic name: treprostinil
Company: SteadyMed Ltd.
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 Status and FDA Approval Process for Trevyent

DateArticle
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
May  7, 2015SteadyMed Submits Application for Orphan Drug Designation for Trevyent

Further information

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