Issued to AFT Pharmaceuticals Ltd. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 25, 2024Application
NDA 505b1 • 218528
Product
SCOMARA
Company
AFT Pharmaceuticals Ltd
Review center
CDERStage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, Facility inspection and CGMP compliance. 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 AFT Pharmaceuticals Ltd on January 25, 2024.
NDA 218528 is the application under which FDA issued this complete response letter for SCOMARA to AFT Pharmaceuticals Ltd. 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.