Issued to Otsuka Pharmaceutical Company, Ltd.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 26, 2012Application
NDA 505b1 • 202971
Product
ABILIFY MAINTENA KIT
Company
Otsuka Pharmaceutical Company, Ltd.
Stage
Final Decision
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Facility inspection and CGMP compliance. 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 Otsuka Pharmaceutical Company, Ltd. on July 26, 2012.
NDA 202971 is the application under which FDA issued this complete response letter for ABILIFY MAINTENA KIT to Otsuka Pharmaceutical Company, Ltd.. The letter is dated July 26, 2012.
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.