Issued to Camargo Pharmaceutical Services. Application reviewed but not approved; deficiencies must be corrected.
Issued
April 15, 2016Application
NDA 505b1 • 208232
Product
MYCAPSSA
Company
Camargo Pharmaceutical Services
Review center
Other
Stage
Final Decision
Response due
December 31, 2020
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, Bioequivalence and pharmacokinetics, Statistical analysis. 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 Camargo Pharmaceutical Services on April 15, 2016.
NDA 208232 is the application under which FDA issued this complete response letter for MYCAPSSA to Camargo Pharmaceutical Services. It was reviewed by FDA Other. The letter is dated April 15, 2016.
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.