← FDA DRUG APPROVALS

FDA NDA · NDA213378

LYBALVI

olanzapine and samidorphan l-malate

Sponsor: ALKERMES INC

APPLICATION
NDA213378
TYPE
NDA
ORIGINAL APPROVAL
2021-05-28
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LYBALVI · ReferencePrescription
OLANZAPINE 15MG, SAMIDORPHAN L-MALATE EQ 10MG BASE · TABLET · ORAL
LYBALVI · ReferencePrescription
OLANZAPINE 5MG, SAMIDORPHAN L-MALATE EQ 10MG BASE · TABLET · ORAL
LYBALVI · ReferencePrescription
OLANZAPINE 20MG, SAMIDORPHAN L-MALATE EQ 10MG BASE · TABLET · ORAL
LYBALVI · ReferencePrescription
OLANZAPINE 10MG, SAMIDORPHAN L-MALATE EQ 10MG BASE · TABLET · ORAL

Approval history

2026-01-30Labeling · Supplement 11 · standard — Letter ↗AP
2025-02-28Labeling · Supplement 8 · standard — Label ↗AP
2025-01-22Labeling · Supplement 9 · standard — Label ↗AP
2024-01-30Labeling · Supplement 7 · standard — Letter ↗AP
2023-09-25Labeling · Supplement 5 · standard — Label ↗AP
2021-05-28Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP
2021-05-28Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Letter ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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