Issued to Hikma Pharmaceuticals USA Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
October 21, 2024Application
NDA 505b1 • 219045
Product
naloxone HCl, 4 mg, nasal spray
Company
Hikma Pharmaceuticals USA Inc.
Review center
CDERStage
Final Decision
Response due
October 21, 2025
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, 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 Hikma Pharmaceuticals USA Inc. on October 21, 2024.
NDA 219045 is the application under which FDA issued this complete response letter for naloxone HCl, 4 mg, nasal spray to Hikma Pharmaceuticals USA Inc.. It was reviewed by FDA CDER. The letter is dated October 21, 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.