A clinical validation study of Trevyent

Trial Profile

A clinical validation study of Trevyent

Completed
Phase of Trial: Phase I

Latest Information Update: 13 Nov 2017

At a glance

  • Drugs Treprostinil (Primary)
  • Indications Pulmonary arterial hypertension
  • Focus Adverse reactions
  • Most Recent Events

    • 13 Nov 2017 According to a SteadyMed Therapeutics media release, company held an in-person Type A meeting with FDA and has agreed to a path forward with FDA that it expects will allow for the resubmission and acceptance of Trevyent NDA.
    • 28 Sep 2017 According to a SteadyMed Therapeutics media release, the company has submitted a Type A Meeting Request and Briefing Document to the U.S. Food and Drug Administration (FDA) in response to a Refusal to File letter relating to its New Drug Application (NDA) for Trevyent.
    • 31 Aug 2017 According to a SteadyMed Therapeutics media release, the company has announced receipt of a Refusal to File letter from the U.S. Food and Drug Administration (FDA) relating to its New Drug Application (NDA) for Trevyent for the treatment of Pulmonary Arterial Hypertension (PAH).
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top