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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209531
Company: BIOGEN IDEC

Products on NDA 209531

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SPINRAZA	NUSINERSEN SODIUM	EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)	SOLUTION;INTRATHECAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209531

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/23/2016	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/209531Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/209531Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209531s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209531Orig1s013, s014ltr.pdf
04/10/2024	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209531s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209531Orig1s013, s014ltr.pdf
02/17/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209531s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209531Orig1s011ltr.pdf
06/16/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209531s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209531Orig1s010ltr.pdf
06/17/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209531s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209531Orig1s007s008ltr.pdf
06/17/2019	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209531s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209531Orig1s007s008ltr.pdf
10/10/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209531Orig1s005Ltr.pdf
05/14/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209531Orig1s003s004ltr.pdf
05/14/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209531Orig1s003s004ltr.pdf
11/21/2017	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209531s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209531Orig1s002ltr.pdf

Labels for NDA 209531

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209531s013s014lbl.pdf
04/10/2024	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209531s013s014lbl.pdf
02/17/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209531s011lbl.pdf
06/16/2020	SUPPL-10	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209531s010lbl.pdf
06/17/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209531s007s008lbl.pdf
06/17/2019	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209531s007s008lbl.pdf
10/10/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s005lbl.pdf
05/14/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf
05/14/2018	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209531s003s004lbl.pdf
11/21/2017	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209531s002lbl.pdf
12/23/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/209531lbl.pdf

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