Issued to Spes Pharmaceuticals Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 19, 2022Application
NDA 505b1 • 216686
Product
FOCINVEZ
Company
Spes Pharmaceuticals Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
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 Spes Pharmaceuticals Inc. on October 19, 2022.
NDA 216686 is the application under which FDA issued this complete response letter for FOCINVEZ to Spes Pharmaceuticals Inc.. It was reviewed by FDA Other. The letter is dated October 19, 2022.
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.