FDA Drug Approval Package, Dupixent (dupilumab), BLA 761055 — Original Approval & Supplements

This FOIAdocs regulatory document collection brings together FDA approval records for Dupixent (dupilumab), BLA 761055, sponsored by Regeneron Pharmaceuticals. The package contains 72 FDA documents totaling 3,928 pages, organized by original application and supplemental submission.

Instead of locating and downloading individual records across the application history, buyers receive a research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 29 supplemental submissions represented
• 15 FDA review documents
• 28 approval letters
• 29 labeling documents
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: BLA 761055
Product: Dupixent (dupilumab)
Sponsor: Regeneron Pharmaceuticals
Documents: 72
Pages: 3,928
Coverage: Original approval + 29 supplemental submissions represented