Issued to Shilpa Medicare Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
March 10, 2020Application
NDA 505b1 • 212782
Product
BORTEZOMIB
Company
Shilpa Medicare Limited
Review center
Other
Stage
Final Decision
Response due
November 13, 2026
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Safety and adverse events, Chemistry, manufacturing, and controls, Bioequivalence and pharmacokinetics. 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 Shilpa Medicare Limited on March 10, 2020.
NDA 212782 is the application under which FDA issued this complete response letter for BORTEZOMIB to Shilpa Medicare Limited. It was reviewed by FDA Other. The letter is dated March 10, 2020.
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.