Issued to Sedor Pharmaceuticals, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 22, 2019Application
NDA 505b1 • 210864
Product
SESQUIENT
Company
Sedor Pharmaceuticals, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls. 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 Sedor Pharmaceuticals, LLC on March 22, 2019.
NDA 210864 is the application under which FDA issued this complete response letter for SESQUIENT to Sedor Pharmaceuticals, LLC. It was reviewed by FDA Other. The letter is dated March 22, 2019.
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.