Issued to Evoke Pharma, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 1, 2019Application
NDA 505b1 • 209388
Product
GIMOTI
Company
Evoke Pharma, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Safety and adverse events, Chemistry, manufacturing, and controls, Device constituent and human factors. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Evoke Pharma, Inc. on April 1, 2019.
NDA 209388 is the application under which FDA issued this complete response letter for GIMOTI to Evoke Pharma, Inc.. It was reviewed by FDA Other. The letter is dated April 1, 2019.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.