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FDA BLA · BLA761055

DUPIXENT

dupilumab

Sponsor: REGENERON PHARMACEUTICALS

APPLICATION
BLA761055
TYPE
BLA
ORIGINAL APPROVAL
2017-03-28
LATEST ACTION
2026-07-15
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DUPIXENTPrescription
DUPILUMAB 150MG/ML · INJECTABLE · INJECTION

Approval history

2026-07-15Labeling · Supplement 76 · standardAP
2026-04-22Efficacy · Supplement 74 · standard — Letter ↗AP
2026-04-16Labeling · Supplement 82 · standard — Letter ↗AP
2026-02-23Efficacy · Supplement 75 · priority — Label ↗AP
2025-06-18Efficacy · Supplement 70 · priority — Label ↗AP
2025-04-17Efficacy · Supplement 51 · standard — Label ↗AP
2025-04-16Labeling · Supplement 72 · standard — Label ↗AP
2024-09-27Efficacy · Supplement 64 · priority — Label ↗AP
2024-09-12Efficacy · Supplement 66 · priority — Label ↗AP
2024-04-12Labeling · Supplement 59 · standard — Label ↗AP
2024-01-25Efficacy · Supplement 57 · priority — Label ↗AP
2024-01-12Efficacy · Supplement 55 · standard — Label ↗AP
2023-09-29Labeling · Supplement 54 · standard — Letter ↗AP
2023-07-14Labeling · Supplement 50 · standard — Letter ↗AP
2022-10-17Labeling · Supplement 46 · standard — Label ↗AP
2022-09-28Efficacy · Supplement 44 · priority — Label ↗AP
2022-06-07Efficacy · Supplement 42 · priority — Letter ↗AP
2022-05-20Efficacy · Supplement 40 · priority — Label ↗AP
2021-12-22Labeling · Supplement 27 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 33 · standard — Letter ↗AP
2021-12-22Labeling · Supplement 21 · standard — Letter ↗AP
2021-10-20Efficacy · Supplement 31 · standard — Letter ↗AP
2021-10-01Labeling · Supplement 35 · standard — Label ↗AP
2021-06-14Efficacy · Supplement 16 · standard — Letter ↗AP
2020-06-18Efficacy · Supplement 17 · standard — Letter ↗AP
2020-06-18Labeling · Supplement 15 · standard — Letter ↗AP
2020-05-26Efficacy · Supplement 20 · priority — Label ↗AP
2019-06-26Efficacy · Supplement 14 · priority — Letter ↗AP
2019-03-11Efficacy · Supplement 12 · priority — Label ↗AP
2018-10-19Efficacy · Supplement 7 · standard — Label ↗AP
2018-04-10Efficacy · Supplement 3 · standard — Label ↗AP
2018-01-10Labeling · Supplement 5 · standard — Label ↗AP
2017-03-28Type 1 - New Molecular Entity · Original · priority — 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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