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Drugs@FDA: FDA-Approved Drugs

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