Issued to Hospira, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 19, 2018Application
NDA 505b1 • 210282
Product
DAPTOMYCIN
Company
Hospira, 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 Safety and adverse events, Labeling, packaging, and proprietary name, Clinical efficacy and substantial evidence, 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 Hospira, Inc. on March 19, 2018.
NDA 210282 is the application under which FDA issued this complete response letter for DAPTOMYCIN to Hospira, Inc.. It was reviewed by FDA Other. The letter is dated March 19, 2018.
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.