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SUPPLEMENT APPROVAL.pdf

020450Orig1s040ltr.pdf
Preview of SUPPLEMENT APPROVAL
🔗 Source: accessdata.fda.gov
📊 Size: 162 KB
👤 Author: FDA
⬇️ Downloads: 123

Summary

The FDA has approved a supplemental new drug application (sNDA) for Cerebyx (fosphenytoin sodium) injection, which includes the addition of dosing tables, effective as of the date of the letter. The applicant must submit the content of labeling in structured product labeling (SPL) format within 14 days, and amend all pending supplemental applications with the updated labeling. The applicant is exempt from the Pediatric Research Equity Act (PREA) requirement. The FDA also provides guidance on submitting promotional materials and reminds the applicant of reporting requirements for an approved NDA.

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Description

The FDA has approved a supplemental new drug application (sNDA) for Cerebyx (fosphenytoin sodium) injection, which includes the addition of dosing tables,...

Technical Information

  • File Format: PDF
  • File Size: 162 KB
  • Pages: 4
  • Language: EN
  • Author: FDA
  • Total Downloads: 123
  • Last Updated: 1 month ago

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