← FDA DRUG APPROVALS

FDA BLA · BLA125104

TYSABRI

natalizumab

Sponsor: BIOGEN IDEC

APPLICATION
BLA125104
TYPE
BLA
ORIGINAL APPROVAL
2004-11-23
LATEST ACTION
2025-03-18
ROUTE
INTRAVENOUS, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

TYSABRIPrescription
NATALIZUMAB 300MG · VIAL · SINGLE-USE

Approval history

2025-03-18Labeling · Supplement 984 · standard — Letter ↗AP
2023-10-30Labeling · Supplement 981 · standardAP
2023-10-25Labeling · Supplement 980 · standard — Label ↗AP
2023-08-24REMS · Supplement 977 — Letter ↗AP
2023-04-11Labeling · Supplement 979 · standard — Label ↗AP
2023-04-11REMS · Supplement 976 — Label ↗AP
2021-12-10Labeling · Supplement 975 · standard — Letter ↗AP
2021-12-10Labeling · Supplement 973 · standard — Letter ↗AP
2020-10-05REMS · Supplement 971 — Letter ↗AP
2020-06-17REMS · Supplement 969 — Letter ↗AP
2020-06-17Labeling · Supplement 968 · standard — Letter ↗AP
2020-04-21REMS · Supplement 967AP
2019-08-05Labeling · Supplement 966 · standard — Label ↗AP
2019-01-04Labeling · Supplement 965 · standardAP
2018-04-18Labeling · Supplement 960 · standard — Label ↗AP
2018-04-18Labeling · Supplement 963 · standard — Label ↗AP
2017-08-16Labeling · Supplement 959 · standard — Label ↗AP
2016-09-22REMS · Supplement 958 — Letter ↗AP
2016-05-18Labeling · Supplement 955 · standard — Letter ↗AP
2016-05-18Labeling · Supplement 953 · standard — Label ↗AP
2015-05-12Labeling · Supplement 950 · standard — Label ↗AP
2013-12-15Efficacy · Supplement 840 · standard — Label ↗AP
2013-12-15Labeling · Supplement 847 · standard — Label ↗AP
2013-12-15Labeling · Supplement 889 · standard — Label ↗AP
2013-05-24Labeling · Supplement 813 · standard — Label ↗AP
2012-01-20Efficacy · Supplement 576 · standard — Label ↗AP
2011-10-07Labeling · Supplement 570 · standard — Letter ↗AP
2011-09-16Labeling · Supplement 658 · standard — Label ↗AP
2011-04-01Labeling · Supplement 438 · standard — Label ↗AP
2011-04-01Labeling · Supplement 475 · standard — Label ↗AP
2010-01-21Labeling · Supplement 48 · standardAP
2010-01-21Labeling · Supplement 283 · standard — Label ↗AP
2008-10-03Efficacy · Supplement 67 · standard — Label ↗AP
2008-10-03Supplement · Supplement 98AP
2008-08-25Labeling · Supplement 106 · standard — Letter ↗AP
2008-08-12Labeling · Supplement 89 · standardAP
2008-01-14Efficacy · Supplement 33 · standard — Label ↗AP
2006-06-05Efficacy · Supplement 15 · priority — Label ↗AP
2004-11-23Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →