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FDA BLA · BLA761089

AJOVY

fremanezumab-vfrm

Sponsor: TEVA PHARMS USA

APPLICATION
BLA761089
TYPE
BLA
ORIGINAL APPROVAL
2018-09-14
LATEST ACTION
2026-06-05
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AJOVYPrescription
FREMANEZUMAB-VFRM 150MG/ML · INJECTABLE · INJECTION

Approval history

2026-06-05Labeling · Supplement 36 · standard — Letter ↗AP
2025-08-05Efficacy · Supplement 31 · priority — Label ↗AP
2025-03-21Labeling · Supplement 30 · standard — Label ↗AP
2021-09-24Labeling · Supplement 13 · standard — Letter ↗AP
2020-01-27Efficacy · Supplement 2 · standard — Letter ↗AP
2018-09-14Type 1 - New Molecular Entity · Original · priority — 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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