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FDA BLA · BLA761024

AMJEVITA

adalimumab-atto

Sponsor: AMGEN INC

APPLICATION
BLA761024
TYPE
BLA
ORIGINAL APPROVAL
2016-09-23
LATEST ACTION
2025-10-16
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AMJEVITAPrescription
ADALIMUMAB-ATTO 40MG/0.8ML · INJECTABLE · INJECTION
AMJEVITAPrescription
ADALIMUMAB-ATTO 20MG/0.4ML · INJECTABLE · INJECTION

Approval history

2025-10-16BIOSIMILAR · Supplement 26 — Label ↗AP
2025-09-17Labeling · Supplement 22 · standard — Letter ↗AP
2025-05-20Efficacy · Supplement 21 · standard — Letter ↗AP
2025-04-07Efficacy · Supplement 23 · standard — Label ↗AP
2024-08-20Efficacy · Supplement 19 · standard — Letter ↗AP
2023-08-14Efficacy · Supplement 15 · standard — Letter ↗AP
2023-07-12UNKNOWN · Supplement 17 — Letter ↗AP
2023-04-06Manufacturing (CMC) · Supplement 11 — Label ↗AP
2023-03-22Efficacy · Supplement 12 · standard — Letter ↗AP
2022-07-28Efficacy · Supplement 10 · standard — Letter ↗AP
2019-06-13Labeling · Supplement 4 · standard — Label ↗AP
2018-03-15Labeling · Supplement 3 · standard — Label ↗AP
2016-09-23Type 2 New Active Ingredient and Type 4 New Combination · Original · standard — Letter ↗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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