Issued to Corium, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 23, 2020Application
NDA 505b1 • 212304
Product
ADLARITY
Company
Corium, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Bioequivalence and pharmacokinetics, Safety and adverse events. 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 Corium, Inc. on July 23, 2020.
NDA 212304 is the application under which FDA issued this complete response letter for ADLARITY to Corium, Inc.. It was reviewed by FDA Other. The letter is dated July 23, 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.