Issued to Hikma Pharmaceuticals USA Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
February 28, 2020Application
NDA 505b1 • 212045
Product
KLOXXADO
Company
Hikma Pharmaceuticals USA Inc.
Review center
Other
Stage
Final Decision
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, Statistical analysis. 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 Hikma Pharmaceuticals USA Inc. on February 28, 2020.
NDA 212045 is the application under which FDA issued this complete response letter for KLOXXADO to Hikma Pharmaceuticals USA Inc.. It was reviewed by FDA Other. The letter is dated February 28, 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.