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Evoke Pharma Announces Positive Non-Clinical Pre-NDA Meeting with FDA for Gimoti

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EVOK

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Additional Information

Additional Relevant Details Evoke Pharma has completed a pre‑New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, Gimoti™, its patented nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The focus of this pre-NDA meeting with the FDA was the content of the regulatory, chemistry, manufacturing, and control (CMC), and non-clinical sections of the Company’s planned 505(b)(2) NDA for Gimoti.
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Catalyst Date
Occurred on:
Sep 07, 2016
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Related Keywords Gimoti, Pre-nda Meeting, Nasal Delivery Formulation Of Metoclopramide, Diabetic Gastroparesis