Issued to Azurity Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 28, 2021Application
NDA 505b1 • 213593
Product
KONVOMEP
Company
Azurity 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, Chemistry, manufacturing, and controls, Device constituent and human factors, Bioequivalence and pharmacokinetics. 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 Azurity Pharmaceuticals, Inc. on January 28, 2021.
NDA 213593 is the application under which FDA issued this complete response letter for KONVOMEP to Azurity Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated January 28, 2021.
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.