FDA
approval
· 2023-09-25
FDA Approved: LYBALVI — Supplemental Application (Alkermes, Inc.)
Summary
FDA approved a supplemental application for LYBALVI (olanzapine and samidorphan L-malate) from Alkermes. The action pertains to changes to the product's labelin…
Upgrade for the full analysis, importance score, and drug timeline.
Diseases / indications
Drugs mentioned
Snippet
SUPPL AP for LYBALVI (OLANZAPINE AND SAMIDORPHAN L-MALATE)