Issued to Par Sterile Products, LLC. Application reviewed but not approved; deficiencies must be corrected.
Issued
May 18, 2020Application
NDA 505b1 • 212156
Product
MICAFUNGIN
Company
Par Sterile Products, LLC
Review center
Other
Stage
Final Decision
Response due
January 1, 2022
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events, Clinical efficacy and substantial evidence. 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 Par Sterile Products, LLC on May 18, 2020.
NDA 212156 is the application under which FDA issued this complete response letter for MICAFUNGIN to Par Sterile Products, LLC. It was reviewed by FDA Other. The letter is dated May 18, 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.