Catalyst Wire Dossier Catalyst Wire Dossier
FDA approval · 2025-02-28

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

View source ↗

Summary

FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan) expanding its labeling to include use for schizophrenia and to reduce olanzapin…

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)