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FDA BLA · BLA761063

EMGALITY

galcanezumab-gnlm

Sponsor: ELI LILLY AND CO

APPLICATION
BLA761063
TYPE
BLA
ORIGINAL APPROVAL
2018-09-27
LATEST ACTION
2026-06-05
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EMGALITYPrescription
GALCANEZUMAB-GNLM 120MG/ML · INJECTABLE · INJECTION

Approval history

2026-06-05Labeling · Supplement 13 · standard — Letter ↗AP
2025-03-21Labeling · Supplement 10 · standard — Label ↗AP
2022-05-24Labeling · Supplement 6 · standard — Letter ↗AP
2019-12-05Labeling · Supplement 4 · standard — Letter ↗AP
2019-06-04Efficacy · Supplement 3 · priority — Label ↗AP
2018-09-27Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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