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FDA BLA · BLA103976

XOLAIR

omalizumab

Sponsor: GENENTECH

APPLICATION
BLA103976
TYPE
BLA
ORIGINAL APPROVAL
2003-06-20
LATEST ACTION
2024-02-16
ROUTE
SUBCUTANEOUS
DOSAGE FORM
VIAL, SYRINGE
MARKETING STATUS
Prescription

Products

XOLAIRPrescription
OMALIZUMAB 150MG/VIAL · VIAL
XOLAIRPrescription
OMALIZUMAB 300MG/2ML · SYRINGE
XOLAIRPrescription
OMALIZUMAB 75MG/0.5ML · SYRINGE
XOLAIRPrescription
OMALIZUMAB 150MG/ML · SYRINGE

Approval history

2024-02-16Efficacy · Supplement 5245 · priority — Label ↗AP
2023-08-17Manufacturing (CMC) · Supplement 5242 · unknown — Label ↗AP
2023-03-17Labeling · Supplement 5243 · standard — Letter ↗AP
2021-07-22Manufacturing (CMC) · Supplement 5239 · standard — Label ↗AP
2021-04-09Efficacy · Supplement 5238 · standard — Label ↗AP
2020-11-30Efficacy · Supplement 5235 · standard — Label ↗AP
2019-05-01Labeling · Supplement 5234 · standard — Letter ↗AP
2018-09-28Efficacy · Supplement 5231 · priority — Letter ↗AP
2016-07-06Efficacy · Supplement 5225 · standard — Pediatric Medical Review ↗AP
2015-12-03Labeling · Supplement 5224 · standard — Label ↗AP
2014-09-26Efficacy · Supplement 5161 · standard — Label ↗AP
2014-03-21Efficacy · Supplement 5211 · standard — Review ↗AP
2011-12-22Labeling · Supplement 5191 · standard — Letter ↗AP
2010-12-21Labeling · Supplement 5180 · standard — Letter ↗AP
2010-07-30Labeling · Supplement 5165 · standardAP
2010-01-04Efficacy · Supplement 5166 · standard — Letter ↗AP
2009-07-24Labeling · Supplement 5154 · standardAP
2007-07-02Labeling · Supplement 5102 · standard — Label ↗AP
2006-04-07Supplement · Supplement 5087 — Label ↗AP
2003-06-20Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗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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