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FDA BLA · BLA125326

KESIMPTA

ofatumumab

Sponsor: NOVARTIS

APPLICATION
BLA125326
TYPE
BLA
ORIGINAL APPROVAL
2009-10-26
LATEST ACTION
2026-04-01
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
SOLUTION, INJECTABLE
MARKETING STATUS
Prescription

Products

KESIMPTAPrescription
OFATUMUMAB 20MG/0.4ML · SOLUTION · SUBCUTANEOUS
ARZERRAPrescription
OFATUMUMAB 100MG/5ML · INJECTABLE · INJECTION

Approval history

2026-04-01Labeling · Supplement 84 · standard — Label ↗AP
2025-08-18Labeling · Supplement 83 · standard — Letter ↗AP
2024-04-12Labeling · Supplement 79 · standard — Label ↗AP
2024-01-19Labeling · Supplement 80 · standard — Label ↗AP
2022-09-02Labeling · Supplement 75 · standard — Letter ↗AP
2020-08-20Efficacy · Supplement 70 · priority — Label ↗AP
2016-08-30Efficacy · Supplement 63 · priority — Letter ↗AP
2016-01-19Efficacy · Supplement 62 · priority — Label ↗AP
2014-04-17Efficacy · Supplement 60 · priority — Label ↗AP
2013-09-24Labeling · Supplement 59 · standard — Label ↗AP
2011-09-20Labeling · Supplement 32 · standard — Label ↗AP
2010-09-23Labeling · Supplement 12 · standardAP
2009-10-26Type 1 - New Molecular Entity · Original · priority — Review ↗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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