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FDA approval · 2023-09-25

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

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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…

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Diseases / indications

Drugs mentioned

  • LYBALVI (olanzapine and samidorphan L-malate)

Snippet

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