SteadyMed (NASDAQ: STDY) shares are down 35% this morning after the company said it has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) related to its New Drug Application (NDA) for Trevyent®. The Trevyent NDA was submitted in June 2017 for the treatment of Pulmonary Arterial Hypertension (PAH). Upon preliminary review of the NDA, the FDA determined that it was not adequately complete to permit a substantive review. The FDA has requested more details regarding certain device specifications and performance testing. The FDA also requested further design verification and validation testing on the final, to-be-marketed Trevyent product. The company intends to request a Type A meeting with the FDA within the next 30 days to gain clarification for resubmission. “We believe that the issues raised in the letter from FDA can be sufficiently addressed. Our next step is to work with the FDA to address the open issues and identify a path to a successful resubmission and acceptance of our application,” SteadyMed president and CEO Jonathan M. N. Rigby stated in the news release.
To view the full press release, visit: http://nnw.fm/5rkbY
SteadyMed Ltd. is a specialty pharmaceutical company focused on the development of drug products to treat orphan and high value diseases with unmet parenteral delivery needs. SteadyMed intends to commercialize Trevyent in the U.S. and has signed an exclusive license and supply agreement with Cardiome Pharma Corp. for the commercialization of Trevyent in Europe, Canada and the Middle East. SteadyMed has offices in San Ramon, California and Rehovot, Israel. For additional information about SteadyMed please visit www.steadymed.com.
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