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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 103976
Company: GENENTECH

Medication Guide

Other Important Information from FDA

Products on BLA 103976

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XOLAIR	OMALIZUMAB	150MG/VIAL	VIAL	Prescription	None	No	No
XOLAIR	OMALIZUMAB	75MG/0.5ML	SYRINGE	Prescription	None	No	No
XOLAIR	OMALIZUMAB	150MG/ML	SYRINGE	Prescription	None	No	No
XOLAIR	OMALIZUMAB	300MG/2ML	SYRINGE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 103976

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/2003	ORIG-1	Approval		N/A	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/omalgen062003L.htm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-5245	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/103976Orig1s5245ltr.pdf
03/17/2023	SUPPL-5243	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976Orig1s5243lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/103976Orig1s5243ltr.pdf
08/17/2023	SUPPL-5242	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976s5242lbl.pdf
07/22/2021	SUPPL-5239	Supplement	Label (PDF) Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf
04/09/2021	SUPPL-5238	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/103976Orig1s5238ltr.pdf
11/30/2020	SUPPL-5235	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103976s5235lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/103976Orig1s5235ltr.pdf
05/01/2019	SUPPL-5234	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103976s5234lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/103976Orig1s5234ltr.pdf
09/28/2018	SUPPL-5231	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103976Orig1s5231ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/103976Orig1s5231.pdf
07/06/2016	SUPPL-5225	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/103976Orig1s5225ltr.pdf
12/03/2015	SUPPL-5224	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103976Orig1s5224ltr.pdf
03/21/2014	SUPPL-5211	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5211ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/103976Orig1s5211.pdf
12/22/2011	SUPPL-5191	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/103976s5191ltr.pdf
12/21/2010	SUPPL-5180	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5180ltr.pdf
01/04/2010	SUPPL-5166	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/103976s5166ltr.pdf
07/30/2010	SUPPL-5165	Supplement		Label is not available on this site.
09/26/2014	SUPPL-5161	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/103976Orig1s5161ltr.pdf
07/24/2009	SUPPL-5154	Supplement		Label is not available on this site.
07/02/2007	SUPPL-5102	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
04/07/2006	SUPPL-5087	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/103976s5097ltr.pdf

Labels for BLA 103976

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/16/2024	SUPPL-5245	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf
08/17/2023	SUPPL-5242	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976s5242lbl.pdf
03/17/2023	SUPPL-5243	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976Orig1s5243lbl.pdf
03/17/2023	SUPPL-5243	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/103976Orig1s5243lbl.pdf
07/22/2021	SUPPL-5239	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf
07/22/2021	SUPPL-5239	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5239lbl.pdf
04/09/2021	SUPPL-5238	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/103976s5238lbl.pdf
11/30/2020	SUPPL-5235	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/103976s5235lbl.pdf
05/01/2019	SUPPL-5234	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/103976s5234lbl.pdf
09/28/2018	SUPPL-5231	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/103976s5231lbl.pdf
07/06/2016	SUPPL-5225	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/103976s5225lbl.pdf
12/03/2015	SUPPL-5224	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103976s5224lbl.pdf
09/26/2014	SUPPL-5161	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5161lbl.pdf
03/21/2014	SUPPL-5211	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/103976s5211lbl.pdf
07/02/2007	SUPPL-5102	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103976s5102lbl.pdf
04/07/2006	SUPPL-5087	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/103976s5097lbl.pdf
06/20/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf

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