Issued to Hikma Pharmaceuticals USA, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
January 23, 2024Application
NDA 505b1 • 218258
Product
phenobarbital sodium injection
Company
Hikma Pharmaceuticals USA, Inc.
Review center
CDERStage
Final Decision
Response due
January 22, 2025
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, 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 Hikma Pharmaceuticals USA, Inc. on January 23, 2024.
NDA 218258 is the application under which FDA issued this complete response letter for phenobarbital sodium injection to Hikma Pharmaceuticals USA, Inc.. It was reviewed by FDA CDER. The letter is dated January 23, 2024.
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.