Issued to Sarfez Pharmaceuticals Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 10, 2020Application
NDA 505b1 • 213218
Product
SOAANZ
Company
Sarfez Pharmaceuticals Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, 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 Sarfez Pharmaceuticals Inc. on January 10, 2020.
NDA 213218 is the application under which FDA issued this complete response letter for SOAANZ to Sarfez Pharmaceuticals Inc.. It was reviewed by FDA Other. The letter is dated January 10, 2020.
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.