Drugs@FDA: FDA Approved Drug Products

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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 12MG/5ML (2.4MG/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
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
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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