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FDA BLA · BLA761053

OCREVUS

ocrelizumab

Sponsor: GENENTECH INC

APPLICATION
BLA761053
TYPE
BLA
ORIGINAL APPROVAL
2017-03-28
LATEST ACTION
2026-05-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OCREVUSPrescription
OCRELIZUMAB 30MG/1ML · INJECTABLE · INJECTION

Approval history

2026-05-08Efficacy · Supplement 38 · priority — Label ↗AP
2025-08-18Labeling · Supplement 36 · standard — Letter ↗AP
2024-06-21Labeling · Supplement 35 · standard — Label ↗AP
2024-01-19Labeling · Supplement 34 · standard — Label ↗AP
2023-08-18Labeling · Supplement 31 · standard — Label ↗AP
2022-08-03Labeling · Supplement 29 · standard — Letter ↗AP
2022-08-03Labeling · Supplement 30 · standard — Letter ↗AP
2020-12-14Efficacy · Supplement 22 · standard — Label ↗AP
2020-11-06Labeling · Supplement 23 · standard — Letter ↗AP
2020-05-15Labeling · Supplement 24 · standard — Label ↗AP
2020-01-10Labeling · Supplement 20 · standard — Letter ↗AP
2019-07-16Labeling · Supplement 18 · standard — Label ↗AP
2018-11-12Labeling · Supplement 12 · standard — Label ↗AP
2017-11-02Labeling · Supplement 8 · standardAP
2017-03-28Type 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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