SteadyMed (STDY)

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SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
1 hour 48 minutes ago - DJNF
SteadyMed Announces FDA Agreed Pathway to Trevyent NDA Resubmission
No clinical trials required for NDA resubmission

SAN RAMON, Calif., Dec. 08, 2017 (GLOBE NEWSWIRE) -- SteadyMed Ltd. (Nasdaq:STDY), a specialty pharmaceutical company focused on the development of drug product candidates to treat orphan and high-value diseases with unmet parenteral delivery needs, today announced it has received final minutes from the US Food and Drug Administration (FDA) on the work necessary to resubmit its New Drug Application (NDA) for Trevyent(R) for the treatment of Pulmonary Arterial Hypertension (PAH).

The minutes followed a positive and collaborative Type A meeting with the FDA on November 1, 2017. The FDA is not requiring SteadyMed to conduct any clinical trials to prove the safety or efficacy of Trevyent and has agreed that a repeat of in vitro Design Verification (DV) testing on the final to-be-marketed Trevyent product, supported by pharmacokinetic modelling and Process Validation, should be adequate for the resubmission and acceptance of the 505(b)(2) New Drug Application (NDA).