Issued to Mapi Pharma Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 8, 2024Application
NDA 505b1 • 218223
Product
GA Depot
Company
Mapi Pharma Ltd.
Review center
CDERStage
Final Decision
Response due
March 8, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Clinical efficacy and substantial evidence, Labeling, packaging, and proprietary name, Safety and adverse events, Statistical analysis. 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 Mapi Pharma Ltd. on March 8, 2024.
NDA 218223 is the application under which FDA issued this complete response letter for GA Depot to Mapi Pharma Ltd.. It was reviewed by FDA CDER. The letter is dated March 8, 2024.
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.