Posted by Michael Wonder on 03 Sep 2017
SteadyMed receives refusal to file letter from FDA for Trevyent new drug application
31 August 2017 - Company to meet and work with FDA to address issues raised.
SteadyMed today announced receipt of a refusal to file letter from the U.S. FDA relating to its new drug application for Trevyent for the treatment of pulmonary arterial hypertension.
Based on a preliminary review of the application, which was submitted in June 2017, the FDA determined that the application is not sufficiently complete to permit a substantive review. FDA has requested further information on certain device specifications and performance testing and has requested additional design verification and validation testing on the final, to-be-marketed Trevyent product. Within the next 30 days, the Company will request a Type A meeting with the FDA to gain further clarification on the additional information required for resubmission and acceptance of the NDA. The Company will provide further guidance after the anticipated meeting with FDA.
