BIOGEN IDEC FDA Approval BLA 125104

Application #125104

Documents

Letter	2004-11-24
Letter	2008-01-23
Letter	2008-11-03
Letter	2008-11-03
Letter	2012-01-31
Letter	2013-05-28
Letter	2013-12-17
Letter	2013-12-17
Letter	2016-05-20
Letter	2016-05-20
Label	2004-11-24
Label	2008-10-31
Label	2004-11-23
Label	2011-04-07
Label	2011-04-07
Label	2012-01-27
Label	2013-12-17
Label	2016-05-20
Review	2005-03-08
Review	2013-10-23
Other	2012-01-18
Summary Review	2014-01-16
Letter	2006-06-06
Letter	2012-01-31
Letter	2013-12-17
Letter	2015-05-13
Label	2006-06-06
Label	2008-01-15
Label	2009-09-16
Label	2011-09-27
Label	2013-06-04
Label	2013-12-17
Label	2013-12-17
Label	2015-05-13
Label	2016-05-20
Letter	2016-10-12
Label	2017-08-17
Medication Guide	2017-08-17
Letter	2017-08-21
Label	2018-04-20
Label	2018-04-20
Letter	2018-04-23
Letter	2018-04-23
Label	2019-08-06
Medication Guide	2019-08-06
Letter	2019-08-07
Letter	2020-06-19
Letter	2020-06-18
Label	2020-06-18
Label	2020-06-18
Medication Guide	2020-06-18
Medication Guide	2020-06-18
Medication Guide	2020-10-06
Letter	2020-10-09
Letter	2021-12-14
Letter	2021-12-14
Label	2021-12-15
Label	2021-12-15
Medication Guide	2021-12-15

Application Sponsors

BLA 125104

BIOGEN IDEC

Marketing Status

Prescription

001

Application Products

001

VIAL; SINGLE-USE

300MG

TYSABRI

NATALIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2004-11-23	PRIORITY
EFFICACY; Efficacy	SUPPL	15	AP	2006-06-05	PRIORITY
EFFICACY; Efficacy	SUPPL	33	AP	2008-01-14	STANDARD
LABELING; Labeling	SUPPL	48	AP	2010-01-21	STANDARD
EFFICACY; Efficacy	SUPPL	67	AP	2008-10-03	STANDARD
LABELING; Labeling	SUPPL	89	AP	2008-08-12	STANDARD
S; Supplement	SUPPL	98	AP	2008-10-03
LABELING; Labeling	SUPPL	106	AP	2008-08-25	STANDARD
LABELING; Labeling	SUPPL	283	AP	2010-01-21	STANDARD
LABELING; Labeling	SUPPL	438	AP	2011-04-01	STANDARD
LABELING; Labeling	SUPPL	475	AP	2011-04-01	STANDARD
LABELING; Labeling	SUPPL	570	AP	2011-10-07	STANDARD
EFFICACY; Efficacy	SUPPL	576	AP	2012-01-20	STANDARD
LABELING; Labeling	SUPPL	658	AP	2011-09-16	STANDARD
LABELING; Labeling	SUPPL	813	AP	2013-05-24	STANDARD
EFFICACY; Efficacy	SUPPL	840	AP	2013-12-15	STANDARD
LABELING; Labeling	SUPPL	847	AP	2013-12-15	STANDARD
LABELING; Labeling	SUPPL	889	AP	2013-12-15	STANDARD
LABELING; Labeling	SUPPL	950	AP	2015-05-12	STANDARD
LABELING; Labeling	SUPPL	953	AP	2016-05-18	STANDARD
LABELING; Labeling	SUPPL	955	AP	2016-05-18	STANDARD
REMS; REMS	SUPPL	958	AP	2016-09-22	N/A
LABELING; Labeling	SUPPL	959	AP	2017-08-16	STANDARD
LABELING; Labeling	SUPPL	960	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	963	AP	2018-04-18	STANDARD
LABELING; Labeling	SUPPL	965	AP	2019-01-04	STANDARD
LABELING; Labeling	SUPPL	966	AP	2019-08-05	STANDARD
REMS; REMS	SUPPL	967	AP	2020-04-21	N/A
LABELING; Labeling	SUPPL	968	AP	2020-06-17	STANDARD
REMS; REMS	SUPPL	969	AP	2020-06-17	N/A
REMS; REMS	SUPPL	971	AP	2020-10-05	N/A
LABELING; Labeling	SUPPL	973	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	975	AP	2021-12-10	STANDARD

Submissions Property Types

ORIG	1	Null	27
SUPPL	15	Null	27
SUPPL	98	Null	0
SUPPL	570	Null	7
SUPPL	950	Null	6
SUPPL	953	Null	15
SUPPL	955	Null	7
SUPPL	958	Null	6
SUPPL	959	Null	6
SUPPL	960	Null	7
SUPPL	963	Null	15
SUPPL	965	Null	15
SUPPL	966	Null	7
SUPPL	967	Null	15
SUPPL	968	Null	6
SUPPL	969	Null	6
SUPPL	971	Null	6
SUPPL	973	Null	15
SUPPL	975	Null	15

CDER Filings

BIOGEN IDEC

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site."},{"actionDate":"08\/12\/2008","submission":"SUPPL-89","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/03\/2008","submission":"SUPPL-67","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125104s0067lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125104s067ltr.pdf\"}]","notes":">"},{"actionDate":"01\/21\/2010","submission":"SUPPL-48","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/14\/2008","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/125104s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125104s0033ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2008\\\/125104Orig1s0033.pdf\"}]","notes":">"},{"actionDate":"06\/05\/2006","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125104s015LBL.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125104s015LTR.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125104Orig1s015SumR.pdf\"}]","notes":">"}]
            [actionDate] => 2020-10-05
        )

)

BLA 125104

BIOGEN IDEC

FDA Drug Application

Application #125104

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

BIOGEN IDEC