Steadymed Ltd., of San Ramon, Calif., said it received a refuse-to-file letter from the FDA relating to the NDA for its pulmonary arterial hypertension treatment Trevyent (treprostinil). The FDA requested more information on certain device specifications and performance testing for the Patchpump infusion system used in Trevyent. The FDA also wants additional design verification and validation testing on the final, to-be-marketed Trevyent product. Steadymed plans to request a type A meeting with the FDA in the next 30 days to further clarify what information the FDA needs to resubmit its NDA.