Treats relapsing forms of multiple sclerosis. BLA 125104, held by Biogen Idec. Natalizumab.
As of Nov 13, 2026, BLA 125104 (Tysabri), held by Biogen Idec, was first approved by FDA on Nov 23, 2004, with 38 approved supplements and 0 published complete response letters.
TYSABRI is an integrin receptor antagonist indicated for treatment of: Multiple Sclerosis (MS) TYSABRI is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. TYSABRI increases the risk of PML. When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 15, 2013 | Supplement 840Efficacy (new indication or use) · Standard review | Approved | |
| Jan 20, 2012 | Supplement 576Efficacy (new indication or use) · Standard review | Approved | |
| Oct 3, 2008 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Jan 14, 2008 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jun 5, 2006 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Nov 23, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tysabri300MG · vial; single-use | Natalizumab | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 18, 2025 | Supplement 984Labeling · Standard review | Approved | |
| Oct 30, 2023 | Supplement 981Labeling · Standard review | Approved | None posted |
| Oct 25, 2023 | Supplement 980Labeling · Standard review | Approved | |
| Aug 24, 2023 | Supplement 977REMS | Approved | |
| Apr 11, 2023 | Supplement 979Labeling · Standard review | Approved | |
| Apr 11, 2023 | Supplement 976REMS | Approved | |
| Dec 10, 2021 | Supplement 975Labeling · Standard review | Approved | |
| Dec 10, 2021 | Supplement 973Labeling · Standard review | Approved | |
| Oct 5, 2020 | Supplement 971REMS | Approved | |
| Jun 17, 2020 | Supplement 969REMS | Approved | |
| Jun 17, 2020 | Supplement 968Labeling · Standard review | Approved | |
| Apr 21, 2020 | Supplement 967REMS | Approved | None posted |
| Aug 5, 2019 | Supplement 966Labeling · Standard review | Approved | |
| Jan 4, 2019 | Supplement 965Labeling · Standard review | Approved | None posted |
| Apr 18, 2018 | Supplement 963Labeling · Standard review | Approved | |
| Apr 18, 2018 | Supplement 960Labeling · Standard review | Approved | |
| Aug 16, 2017 | Supplement 959Labeling · Standard review | Approved | |
| Sep 22, 2016 | Supplement 958REMS | Approved | |
| May 18, 2016 | Supplement 955Labeling · Standard review | Approved | |
| May 18, 2016 | Supplement 953Labeling · Standard review | Approved | |
| May 12, 2015 | Supplement 950Labeling · Standard review | Approved | |
| Dec 15, 2013 | Supplement 889Labeling · Standard review | Approved | |
| Dec 15, 2013 | Supplement 847Labeling · Standard review | Approved | |
| Dec 15, 2013 | Supplement 840Efficacy (new indication or use) · Standard review | Approved | |
| May 24, 2013 | Supplement 813Labeling · Standard review | Approved | |
| Jan 20, 2012 | Supplement 576Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2011 | Supplement 570Labeling · Standard review | Approved | |
| Sep 16, 2011 | Supplement 658Labeling · Standard review | Approved | |
| Apr 1, 2011 | Supplement 475Labeling · Standard review | Approved | |
| Apr 1, 2011 | Supplement 438Labeling · Standard review | Approved | |
| Jan 21, 2010 | Supplement 283Labeling · Standard review | Approved | |
| Jan 21, 2010 | Supplement 48Labeling · Standard review | Approved | None posted |
| Oct 3, 2008 | Supplement 98 | Approved | None posted |
| Oct 3, 2008 | Supplement 67Efficacy (new indication or use) · Standard review | Approved | |
| Aug 25, 2008 | Supplement 106Labeling · Standard review | Approved | |
| Aug 12, 2008 | Supplement 89Labeling · Standard review | Approved | None posted |
| Jan 14, 2008 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Jun 5, 2006 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Nov 23, 2004 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
