BLA 103628

BIOGEN

FDA Drug Application

Application #103628

Documents

• Letter: 2004-03-11
• Letter: 2004-03-11
• Letter: 2004-03-11
• Letter: 2014-09-03
• Letter: 2015-12-23
• Label: 2004-03-11
• Label: 2007-02-23
• Label: 2012-02-27
• Label: 2014-09-03
• Label: 2013-03-15
• Label: 2015-12-28
• Letter: 2004-03-11
• Letter: 2007-02-12
• Letter: 2014-09-03
• Letter: 2014-09-03
• Letter: 2012-02-29
• Letter: 2012-02-29
• Letter: 2013-03-15
• Letter: 2014-09-03
• Label: 2004-03-11
• Label: 2004-03-11
• Label: 2014-09-03
• Label: 2014-09-03
• Label: 2012-02-27
• Label: 2014-09-03
• Review: 2004-03-11
• Review: 1996-05-17
• Label: 2019-07-15
• Medication Guide: 2019-07-15
• Letter: 2019-07-15
• Letter: 2020-03-30
• Label: 2020-03-31
• Letter: 2021-11-05
• Label: 2021-11-05
• Medication Guide: 2021-11-05

Application Sponsors

BLA 103628

BIOGEN

Marketing Status

• Prescription: 001

Application Products

001

VIAL

30UG/ML

0

AVONEX

INTERFERON BETA-1A

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-05-17	PRIORITY
LABELING; Labeling	SUPPL	1025	AP	2000-06-30	STANDARD
EFFICACY; Efficacy	SUPPL	5001	AP	2003-01-31	STANDARD
EFFICACY; Efficacy	SUPPL	5008	AP	2002-11-12	STANDARD
S; Supplement	SUPPL	5021	AP	2003-05-28
LABELING; Labeling	SUPPL	5050	AP	2003-12-23	STANDARD
LABELING; Labeling	SUPPL	5053	AP	2004-03-26	STANDARD
LABELING; Labeling	SUPPL	5069	AP	2004-12-30	STANDARD
LABELING; Labeling	SUPPL	5074	AP	2005-02-23	STANDARD
LABELING; Labeling	SUPPL	5115	AP	2007-02-02	STANDARD
LABELING; Labeling	SUPPL	5129	AP	2014-08-28	STANDARD
LABELING; Labeling	SUPPL	5132	AP	2007-06-20	STANDARD
LABELING; Labeling	SUPPL	5177	AP	2014-08-28	STANDARD
EFFICACY; Efficacy	SUPPL	5189	AP	2012-02-27	STANDARD
EFFICACY; Efficacy	SUPPL	5191	AP	2012-02-27
LABELING; Labeling	SUPPL	5194	AP	2014-08-28	STANDARD
LABELING; Labeling	SUPPL	5206	AP	2013-03-13	STANDARD
LABELING; Labeling	SUPPL	5224	AP	2014-08-28	STANDARD
LABELING; Labeling	SUPPL	5258	AP	2015-12-22	STANDARD
EFFICACY; Efficacy	SUPPL	5263	AP	2020-03-27	STANDARD
LABELING; Labeling	SUPPL	5264	AP	2019-07-12	STANDARD
LABELING; Labeling	SUPPL	5266	AP	2021-11-03	901 REQUIRED

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	5001	Orphan	5
SUPPL	5008	Orphan	5
SUPPL	5021	Null	0
SUPPL	5129	Null	7
SUPPL	5177	Null	6
SUPPL	5191	Null	0
SUPPL	5194	Null	7
SUPPL	5224	Null	7
SUPPL	5258	Null	7
SUPPL	5263	Null	7
SUPPL	5264	Null	7
SUPPL	5266	Null	7

CDER Filings

BIOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103628
            [companyName] => BIOGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/103628s5264lbl.pdf#page=21"]
            [products] => [{"drugName":"AVONEX","activeIngredients":"INTERFERON BETA-1A","strength":"30UG\/ML","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-5263","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103628s5263lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2019","submission":"SUPPL-5264","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103628s5264lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2019","submission":"SUPPL-5264","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103628s5264lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-5258","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103628s5258lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-5224","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-5194","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-5177","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2014","submission":"SUPPL-5129","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2013","submission":"SUPPL-5206","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103628s5206lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2012","submission":"SUPPL-5191","supplementCategories":"Efficacy-New Route Of Administration","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103628s5191lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2012","submission":"SUPPL-5189","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103628s5189lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2007","submission":"SUPPL-5115","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103628s5115lbl.pdf\"}]","notes":""},{"actionDate":"01\/31\/2003","submission":"SUPPL-5001","supplementCategories":"Efficacy","inserts":"[{\"name\":\"\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbbio013103LB.htm\"}]","notes":""},{"actionDate":"11\/12\/2002","submission":"SUPPL-5008","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbbio111202LB.pdf\"}]","notes":""},{"actionDate":"05\/17\/1996","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1996\\\/ifnbbio051796lb.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/17\/1996","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1996\\\/ifnbbio051796lb.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1996\\\/ifnbbio051796l.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/96\\\/103628Orig1s000rev.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/12\/2019","submission":"SUPPL-5264","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103628s5264lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103628Orig1s5264ltr.pdf\"}]","notes":">"},{"actionDate":"03\/27\/2020","submission":"SUPPL-5263","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103628s5263lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103628Orig1s5263ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2015","submission":"SUPPL-5258","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103628s5258lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103628Orig1s5258ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2014","submission":"SUPPL-5224","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103628Orig1s5129,s5177,s5224,s5194ltr.pdf\"}]","notes":">"},{"actionDate":"03\/13\/2013","submission":"SUPPL-5206","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103628s5206lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103628Orig1s5206ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2014","submission":"SUPPL-5194","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103628Orig1s5129,s5177,s5224,s5194ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2012","submission":"SUPPL-5191","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103628s5191lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103628s5189,s5191ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2012","submission":"SUPPL-5189","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103628s5189lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103628s5189,s5191ltr.pdf\"}]","notes":">"},{"actionDate":"08\/28\/2014","submission":"SUPPL-5177","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103628Orig1s5129,s5177,s5224,s5194ltr.pdf\"}]","notes":">"},{"actionDate":"06\/20\/2007","submission":"SUPPL-5132","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/28\/2014","submission":"SUPPL-5129","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103628s5129s5177s5194s5224lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103628Orig1s5129,s5177,s5224,s5194ltr.pdf\"}]","notes":">"},{"actionDate":"02\/02\/2007","submission":"SUPPL-5115","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/103628s5115lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/23\/2005","submission":"SUPPL-5074","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/30\/2004","submission":"SUPPL-5069","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/26\/2004","submission":"SUPPL-5053","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2003","submission":"SUPPL-5050","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/28\/2003","submission":"SUPPL-5021","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/ifnbbio052803L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2003\\\/103628s5021TOC.cfm\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/12\/2002","submission":"SUPPL-5008","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbbio111202LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/ifnbbio111202L.htm\"}]","notes":">"},{"actionDate":"01\/31\/2003","submission":"SUPPL-5001","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbbio013103LB.htm\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/ifnbbio013103L.htm\"}]","notes":">"},{"actionDate":"06\/30\/2000","submission":"SUPPL-1025","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-03-27
        )

)