SERONO INC FDA Approval BLA 103780

BLA 103780

SERONO INC

FDA Drug Application

Application #103780

Documents

Letter2003-12-17
Letter2013-04-24
Letter2014-04-25
Letter2015-12-23
Label2003-12-17
Label2005-01-26
Label2005-01-26
Label2005-07-21
Label2015-03-12
Review2004-03-26
Letter2004-03-26
Letter2005-01-26
Letter2005-01-26
Letter2005-07-21
Letter2012-12-28
Letter2015-03-11
Letter2014-04-25
Label2004-03-26
Label2012-12-28
Label2013-04-23
Label2014-04-28
Label2014-04-28
Label2015-12-28
Review2003-12-17
Medication Guide2003-12-17
Label2016-09-30
Letter2016-09-30
Letter2019-07-10
Label2019-07-11
Label2020-05-27
Medication Guide2020-05-27
Medication Guide2020-05-27
Label2020-05-27
Letter2020-05-28
Letter2020-05-28
Review2021-01-07
Letter2021-11-05
Label2021-11-05
Medication Guide2021-11-05

Application Sponsors

BLA 103780SERONO INC

Marketing Status

Prescription001
Prescription002

Application Products

001SYRINGE22UG/0.5ML0REBIFINTERFERON BETA-1A
002SYRINGE44UG/0.5ML0REBIFINTERFERON BETA-1A

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2002-03-07UNKNOWN
EFFICACY; EfficacySUPPL5010AP2003-05-02STANDARD
EFFICACY; EfficacySUPPL5027AP2004-03-26STANDARD
LABELING; LabelingSUPPL5030AP2004-12-23STANDARD
S; SupplementSUPPL5052AP2004-12-17
LABELING; LabelingSUPPL5062AP2005-06-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5121AP2012-12-21
LABELING; LabelingSUPPL5140AP2013-04-19STANDARD
LABELING; LabelingSUPPL5172AP2015-03-10STANDARD
LABELING; LabelingSUPPL5178AP2014-04-24STANDARD
LABELING; LabelingSUPPL5179AP2014-04-24STANDARD
LABELING; LabelingSUPPL5194AP2015-12-22STANDARD
EFFICACY; EfficacySUPPL5196AP2016-09-27STANDARD
EFFICACY; EfficacySUPPL5203AP2020-05-26STANDARD
LABELING; LabelingSUPPL5204AP2019-07-09STANDARD
LABELING; LabelingSUPPL5207AP2020-05-26STANDARD
LABELING; LabelingSUPPL5210AP2021-11-03STANDARD

Submissions Property Types

SUPPL5052Null0
SUPPL5121Null0
SUPPL5172Null6
SUPPL5194Null15
SUPPL5196Null15
SUPPL5203Null15
SUPPL5204Null15
SUPPL5207Null15
SUPPL5210Null6

CDER Filings

SERONO INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103780
            [companyName] => SERONO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/103780s5203s5207lbl.pdf#page=16"]
            [products] => [{"drugName":"REBIF","activeIngredients":"INTERFERON BETA-1A","strength":"22UG\/0.5ML","dosageForm":"SYRINGE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"REBIF","activeIngredients":"INTERFERON BETA-1A","strength":"44UG\/0.5ML","dosageForm":"SYRINGE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-5207","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2020","submission":"SUPPL-5203","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2016","submission":"SUPPL-5196","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103780s5196lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2015","submission":"SUPPL-5194","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5194lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2015","submission":"SUPPL-5172","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5172lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2014","submission":"SUPPL-5179","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2014","submission":"SUPPL-5178","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"}]","notes":""},{"actionDate":"04\/19\/2013","submission":"SUPPL-5140","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103780s5140lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2012","submission":"SUPPL-5121","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103780s5121lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"06\/30\/2005","submission":"SUPPL-5062","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103780s5062lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2004","submission":"SUPPL-5030","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5030lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2004","submission":"SUPPL-5052","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5052lbl.pdf\"}]","notes":""},{"actionDate":"05\/02\/2003","submission":"SUPPL-5010","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbser050203LB.pdf\"}]","notes":""},{"actionDate":"03\/07\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbser030702LB.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/07\/2002","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/ifnbser030702LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2002\\\/ifnbser030702L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20170118085129\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080737.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-5207","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103780Orig1s5203s5207ltr.pdf\"}]","notes":">"},{"actionDate":"07\/09\/2019","submission":"SUPPL-5204","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103780s5204lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103780Orig1s5204ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2020","submission":"SUPPL-5203","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103780s5203s5207lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103780Orig1s5203s5207ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2016","submission":"SUPPL-5196","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/103780s5196lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/103780Orig1s5196ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2015","submission":"SUPPL-5194","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5194lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103780Orig1s5194ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2014","submission":"SUPPL-5179","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103780Orig1s5178,s5179ltr.pdf\"}]","notes":">"},{"actionDate":"04\/24\/2014","submission":"SUPPL-5178","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/103780s5178s5179lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/103780Orig1s5178,s5179ltr.pdf\"}]","notes":">"},{"actionDate":"03\/10\/2015","submission":"SUPPL-5172","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/103780s5172lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/103780Orig1s5172ltr.pdf\"}]","notes":">"},{"actionDate":"04\/19\/2013","submission":"SUPPL-5140","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/103780s5140lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/103780Orig1s5140ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2012","submission":"SUPPL-5121","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/103780s5121lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/103780Orig1s5121ltr.pdf\"}]","notes":">"},{"actionDate":"06\/30\/2005","submission":"SUPPL-5062","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/103780s5062lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2005\\\/103780s5062ltr.pdf\"}]","notes":">"},{"actionDate":"12\/17\/2004","submission":"SUPPL-5052","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103780_5052ltr.pdf\"}]","notes":">"},{"actionDate":"12\/23\/2004","submission":"SUPPL-5030","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/103780_5030lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2004\\\/103780_5030ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2004","submission":"SUPPL-5027","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/02\/2003","submission":"SUPPL-5010","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/ifnbser050203LB.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2003\\\/ifnbser050203L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20120303004314\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080739.htm\"}]","notes":">"}]
            [actionDate] => 2020-05-26
        )

)

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