Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2025-10-09

FDA Approved: PRALUENT — Supplemental Application (Regeneron Pharmaceuticals, Inc.)

View source ↗

Summary

FDA approved a supplemental application for PRALUENT (alirocumab) submitted by Regeneron, resulting in changes to the product labeling.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

Drugs mentioned

  • Praluent (alirocumab)

Snippet

SUPPL AP for PRALUENT (ALIROCUMAB)