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FDA BLA · BLA761077

AIMOVIG

erenumab-aooe

Sponsor: AMGEN INC

APPLICATION
BLA761077
TYPE
BLA
ORIGINAL APPROVAL
2018-05-17
LATEST ACTION
2025-06-19
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AIMOVIGPrescription
ERENUMAB-AOOE 70MG/ML · INJECTABLE · INJECTION

Approval history

2025-06-19Labeling · Supplement 25 · standard — Letter ↗AP
2025-03-21Labeling · Supplement 26 · standard — Label ↗AP
2024-08-06Labeling · Supplement 22 · standard — Letter ↗AP
2022-10-03Efficacy · Supplement 15 · standard — Letter ↗AP
2022-09-22Labeling · Supplement 17 · standard — Letter ↗AP
2022-08-15Labeling · Supplement 16 · standard — Letter ↗AP
2022-03-04Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2021-05-11Labeling · Supplement 11 · standard — Label ↗AP
2021-02-03Labeling · Supplement 9 · standard — Label ↗AP
2020-04-30Labeling · Supplement 7 · 901 required — Letter ↗AP
2020-02-15Labeling · Supplement 4 · standard — Label ↗AP
2019-10-04Labeling · Supplement 3 · standard — Label ↗AP
2019-03-11Efficacy · Supplement 1 · standard — Letter ↗AP
2018-05-17Type 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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