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FDA BLA · BLA761178

ADUHELM

Sponsor: BIOGEN INC

APPLICATION
BLA761178
TYPE
BLA
ORIGINAL APPROVAL
2021-06-07
LATEST ACTION
2024-03-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ADUHELMPrescription
ADUCANUMAB-AVWA 170MG/1.7ML (100MG/ML) · INJECTABLE · INJECTION
ADUHELMPrescription
ADUCANUMAB-AVWA 300MG/3ML (100MG/ML) · INJECTABLE · INJECTION

Approval history

2024-03-15Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2023-08-30Labeling · Supplement 11 · standard — Letter ↗AP
2023-02-08Efficacy · Supplement 7 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 5 · standard — Label ↗AP
2021-07-07Labeling · Supplement 3 · standard — Label ↗AP
2021-06-07Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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