Issued to Shilpa Medicare Limited. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 24, 2021Application
NDA 505b1 • 215179
Product
PEMETREXED
Company
Shilpa Medicare Limited
Review center
Other
Stage
Final Decision
Response due
December 31, 2024
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 Shilpa Medicare Limited on June 24, 2021.
NDA 215179 is the application under which FDA issued this complete response letter for PEMETREXED to Shilpa Medicare Limited. It was reviewed by FDA Other. The letter is dated June 24, 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.