Catalyst Wire Dossier Catalyst Wire Dossier
FDA label_change · 2025-12-22

FDA Approved: ZUBSOLV — Supplemental Application (Orexo US, Inc.)

View source ↗

Summary

The FDA approved a supplemental labeling change for ZUBSOLV (buprenorphine/naloxone) from Orexo US, Inc., updating the product labeling.

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

Diseases / indications

Drugs mentioned

  • ZUBSOLV (Buprenorphine hydrochloride and naloxone hydrochloride)

Snippet

SUPPL AP for ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE)