Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125104
Company: BIOGEN IDEC
Company: BIOGEN IDEC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TYSABRI | NATALIZUMAB | 300MG | VIAL; SINGLE-USE | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/23/2004 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/125104_0000_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/125104s000_Natalizumab.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/18/2025 | SUPPL-984 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125104s984lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125104Orig1s984ltr.pdf | |
| 10/30/2023 | SUPPL-981 | Supplement |
Label is not available on this site. |
||
| 10/25/2023 | SUPPL-980 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104Orig1s980lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125104Orig1s980ltr.pdf | |
| 04/11/2023 | SUPPL-979 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125104Orig1s976,s979ltr.pdf | |
| 08/24/2023 | SUPPL-977 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125104Orig1s977ltr.pdf |
| 04/11/2023 | SUPPL-976 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125104Orig1s976,s979ltr.pdf | |
| 12/10/2021 | SUPPL-975 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125104Orig1s973,s975ltr.pdf | |
| 12/10/2021 | SUPPL-973 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125104Orig1s973,s975ltr.pdf | |
| 10/05/2020 | SUPPL-971 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125104Orig1s971Advice_APLtr.pdf |
| 06/17/2020 | SUPPL-969 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125104s968s969lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125104Orig1s968, s969ltr.pdf | |
| 06/17/2020 | SUPPL-968 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125104s968s969lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125104Orig1s968, s969ltr.pdf | |
| 04/21/2020 | SUPPL-967 | Supplement |
Label is not available on this site. |
||
| 08/05/2019 | SUPPL-966 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125104s966lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125104Orig1s966ltr.pdf | |
| 01/04/2019 | SUPPL-965 | Supplement |
Label is not available on this site. |
||
| 04/18/2018 | SUPPL-963 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf | |
| 04/18/2018 | SUPPL-960 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125104Orig1s960s963ltr.pdf | |
| 08/16/2017 | SUPPL-959 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125104Orig1s959ltr.pdf | |
| 09/22/2016 | SUPPL-958 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s958ltr.pdf |
| 05/18/2016 | SUPPL-955 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf | |
| 05/18/2016 | SUPPL-953 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125104Orig1s953,s955ltr.pdf | |
| 05/12/2015 | SUPPL-950 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125104Orig1s950ltr.pdf | |
| 12/15/2013 | SUPPL-889 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf | |
| 12/15/2013 | SUPPL-847 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf | |
| 12/15/2013 | SUPPL-840 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s840,s847,s889ltr.pdf | |
| 05/24/2013 | SUPPL-813 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125104Orig1s813ltr.pdf | |
| 09/16/2011 | SUPPL-658 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf | |
| 01/20/2012 | SUPPL-576 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125104s576ltr.pdf | |
| 10/07/2011 | SUPPL-570 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125104s570ltr.pdf |
| 04/01/2011 | SUPPL-475 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf | |
| 04/01/2011 | SUPPL-438 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf | |
| 01/21/2010 | SUPPL-283 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf | |
| 08/25/2008 | SUPPL-106 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s106ltr.pdf | |
| 10/03/2008 | SUPPL-98 | Supplement |
Label is not available on this site. |
||
| 08/12/2008 | SUPPL-89 | Supplement |
Label is not available on this site. |
||
| 10/03/2008 | SUPPL-67 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf | |
| 01/21/2010 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 01/14/2008 | SUPPL-33 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s0033ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/bla/2008/125104Orig1s0033.pdf | |
| 06/05/2006 | SUPPL-15 | Supplement |
Label (PDF)
Letter (PDF) Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/125104s015LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104Orig1s015SumR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/18/2025 | SUPPL-984 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125104s984lbl.pdf | |
| 03/18/2025 | SUPPL-984 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125104s984lbl.pdf | |
| 10/25/2023 | SUPPL-980 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104Orig1s980lbl.pdf | |
| 04/11/2023 | SUPPL-979 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.pdf | |
| 04/11/2023 | SUPPL-979 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.pdf | |
| 04/11/2023 | SUPPL-976 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125104s976s979lbl.pdf | |
| 12/10/2021 | SUPPL-975 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf | |
| 12/10/2021 | SUPPL-973 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125104s973s975lbl.pdf | |
| 06/17/2020 | SUPPL-969 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125104s968s969lbl.pdf | |
| 06/17/2020 | SUPPL-968 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125104s968s969lbl.pdf | |
| 08/05/2019 | SUPPL-966 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125104s966lbl.pdf | |
| 08/05/2019 | SUPPL-966 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125104s966lbl.pdf | |
| 04/18/2018 | SUPPL-963 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf | |
| 04/18/2018 | SUPPL-963 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf | |
| 04/18/2018 | SUPPL-960 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf | |
| 04/18/2018 | SUPPL-960 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125104s960s963lbl.pdf | |
| 08/16/2017 | SUPPL-959 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf | |
| 08/16/2017 | SUPPL-959 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/1215104s959lbl.pdf | |
| 05/18/2016 | SUPPL-955 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf | |
| 05/18/2016 | SUPPL-953 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf | |
| 05/18/2016 | SUPPL-953 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125104s953s955lbl.pdf | |
| 05/12/2015 | SUPPL-950 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf | |
| 05/12/2015 | SUPPL-950 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf | |
| 05/12/2015 | SUPPL-950 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125104s950lbl.pdf | |
| 12/15/2013 | SUPPL-889 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf | |
| 12/15/2013 | SUPPL-847 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf | |
| 12/15/2013 | SUPPL-840 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s840s847s889lbl.pdf | |
| 05/24/2013 | SUPPL-813 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125104s813lbl.pdf | |
| 01/20/2012 | SUPPL-576 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf | |
| 09/16/2011 | SUPPL-658 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0658lbl.pdf | |
| 04/01/2011 | SUPPL-475 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf | |
| 04/01/2011 | SUPPL-438 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf | |
| 01/21/2010 | SUPPL-283 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125104s283lbl.pdf | |
| 10/03/2008 | SUPPL-67 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s0067lbl.pdf | |
| 08/25/2008 | SUPPL-106 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf | |
| 01/14/2008 | SUPPL-33 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s033lbl.pdf | |
| 06/05/2006 | SUPPL-15 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/125104s015LBL.pdf | |
| 11/23/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/125104lbl.pdf |