Issued to Defender Pharmaceuticals, Inc. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 25, 2024Application
NDA 505b1 • 214315
Product
scopolamine nasal gel
Company
Defender Pharmaceuticals, Inc
Review center
CDERStage
Final Decision
Response due
January 24, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Defender Pharmaceuticals, Inc on January 25, 2024.
NDA 214315 is the application under which FDA issued this complete response letter for scopolamine nasal gel to Defender Pharmaceuticals, Inc. It was reviewed by FDA CDER. The letter is dated January 25, 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.