Issued to Spectrum Pharmaceuticals, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
August 3, 2021Application
BLA • 761148
Product
ROLVEDON
Company
Spectrum Pharmaceuticals, 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 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 Spectrum Pharmaceuticals, Inc. on August 3, 2021.
BLA 761148 is the application under which FDA issued this complete response letter for ROLVEDON to Spectrum Pharmaceuticals, Inc.. It was reviewed by FDA Other. The letter is dated August 3, 2021.
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.