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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125499
Company: BIOGEN IDEC INC

Medication Guide

Summary Review

Products on BLA 125499

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PLEGRIDY	PEGINTERFERON BETA-1A	125MICROGRAMS/0.5ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125499

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/15/2014	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125499s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125499Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-28	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125499Orig1s028ltr.pdf
03/29/2022	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125499Orig1s025ltr.pdf
11/03/2021	SUPPL-23	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125499Orig1s023tr.pdf
01/29/2021	SUPPL-21	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125499Orig1s021ltr.pdf
07/10/2019	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125499Orig1s019ltr.pdf
03/27/2020	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125499Orig1s018ltr.pdf
07/14/2016	SUPPL-11	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125499Orig1s011ltr.pdf
12/22/2015	SUPPL-9	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125499s009ltr.pdf

Labels for BLA 125499

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2023	SUPPL-28	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf
07/28/2023	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125499s028lbl.pdf
03/29/2022	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125499s025lbl.pdf
11/03/2021	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf
11/03/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s023lbl.pdf
01/29/2021	SUPPL-21	Efficacy-New Route Of Administration	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125499s021lbl.pdf
03/27/2020	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125499s018lbl.pdf
07/10/2019	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf
07/10/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125499s019lbl.pdf
07/14/2016	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf
07/14/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125499s011lbl.pdf
12/22/2015	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125499s009lbl.pdf
08/15/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125499lbl.pdf

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