Issued to Marius Pharmaceuticals, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 22, 2021Application
NDA 505b1 • 213953
Product
KYZATREX
Company
Marius Pharmaceuticals, LLC
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, Clinical efficacy and substantial evidence, Safety and adverse events, 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 Marius Pharmaceuticals, LLC on October 22, 2021.
NDA 213953 is the application under which FDA issued this complete response letter for KYZATREX to Marius Pharmaceuticals, LLC. It was reviewed by FDA Other. The letter is dated October 22, 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.