Issued to Amgen Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
July 13, 2017Application
BLA • 761062
Product
EVENITY
Company
Amgen Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 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, 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 Amgen Inc. on July 13, 2017.
BLA 761062 is the application under which FDA issued this complete response letter for EVENITY to Amgen Inc.. It was reviewed by FDA Other. The letter is dated July 13, 2017.
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.