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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125293
Company: HORIZON PHARMA

Medication Guide

Summary Review

Products on BLA 125293

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KRYSTEXXA	PEGLOTICASE	8MG	INJECTABLE; INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125293

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/14/2010	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293s0000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/125293Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2022	SUPPL-104	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125293Orig1s104ltr.pdf
07/13/2018	SUPPL-92	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125293Orig1s092ltr.pdf
08/10/2017	SUPPL-90	Supplement		Label is not available on this site.
09/09/2016	SUPPL-89	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s089ltr.pdf
04/11/2016	SUPPL-86	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s086ltr.pdf
05/10/2016	SUPPL-85	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125293Orig1s085ltr.pdf
07/30/2015	SUPPL-83	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s083ltr.pdf
07/17/2015	SUPPL-81	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125293Orig1s081ltr.pdf
10/10/2013	SUPPL-60	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125293Orig1s060ltr.pdf
04/16/2012	SUPPL-40	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf
04/16/2012	SUPPL-34	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125293s034,s040ltr.pdf
10/19/2010	SUPPL-1	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/125293s001ltr.pdf

Labels for BLA 125293

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/07/2022	SUPPL-104	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125293s104lbl.pdf
07/13/2018	SUPPL-92	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125293s092lbl.pdf
09/09/2016	SUPPL-89	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s089lbl.pdf
05/10/2016	SUPPL-85	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125293s085lbl.pdf
07/17/2015	SUPPL-81	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125293s081lbl.pdf
04/16/2012	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s040lbl.pdf
04/16/2012	SUPPL-34	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf
09/14/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125293s0000lbl.pdf

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