Issued to International Medication Systems, Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
December 12, 2018Application
NDA 505b1 • 211363
Product
EPINEPHRINE
Company
International Medication Systems, Limited
Review center
Other
Stage
Final Decision
Response due
January 1, 2024
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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, Chemistry, manufacturing, and controls. 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 International Medication Systems, Limited on December 12, 2018.
NDA 211363 is the application under which FDA issued this complete response letter for EPINEPHRINE to International Medication Systems, Limited. It was reviewed by FDA Other. The letter is dated December 12, 2018.
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.