Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2026-01-30

FDA Approved: LYBALVI — Supplemental Application (Alkermes, Inc.)

View source ↗

Summary

The FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan L-malate) from Alkermes, Inc., resulting in labeling changes under the suppl…

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

Diseases / indications

Drugs mentioned

  • LYBALVI (olanzapine and samidorphan L-malate)

Snippet

SUPPL AP for LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE)