NOVARTIS PHARMS FDA Approval BLA 125319

Application #125319

Documents

Letter	2013-05-13
Letter	2014-10-21
Letter	2016-07-26
Label	2009-06-29
Label	2012-04-02
Letter	2009-06-30
Letter	2012-04-02
Letter	2012-10-15
Label	2012-10-12
Label	2013-05-13
Label	2014-10-21
Label	2016-07-22
Review	2009-08-26
Medication Guide	2013-05-15
Summary Review	2009-08-26
Label	2016-09-27
Label	2016-09-27
Label	2016-09-27
Letter	2016-09-26
Letter	2016-09-26
Letter	2016-09-26
Label	2016-12-22
Letter	2016-12-23
Review	2017-12-29
Review	2017-12-29
Review	2017-12-29
Medication Guide	2018-11-08
Letter	2020-06-17
Label	2020-06-17
Medication Guide	2020-06-17
Letter	2020-09-21
Label	2020-09-22
Medication Guide	2020-09-22

Application Sponsors

BLA 125319

NOVARTIS PHARMS

Marketing Status

Prescription

001

Application Products

001

INJECTABLE; SUBCUTANEOUS

180MG

ILARIS

CANAKINUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-06-17	PRIORITY
LABELING; Labeling	SUPPL	14	AP	2011-11-17	STANDARD
LABELING; Labeling	SUPPL	47	AP	2012-03-30	STANDARD
LABELING; Labeling	SUPPL	54	AP	2012-10-11	STANDARD
EFFICACY; Efficacy	SUPPL	62	AP	2013-05-09	PRIORITY
LABELING; Labeling	SUPPL	81	AP	2014-10-16	STANDARD
EFFICACY; Efficacy	SUPPL	84	AP	2016-07-21	STANDARD
EFFICACY; Efficacy	SUPPL	85	AP	2016-09-23	PRIORITY
EFFICACY; Efficacy	SUPPL	86	AP	2016-09-23	PRIORITY
EFFICACY; Efficacy	SUPPL	87	AP	2016-09-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	88	AP	2016-12-22	STANDARD
EFFICACY; Efficacy	SUPPL	97	AP	2020-06-16	PRIORITY
LABELING; Labeling	SUPPL	100	AP	2020-09-18	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	62	Orphan	5
SUPPL	81	Null	7
SUPPL	84	Null	6
SUPPL	85	Null	6
SUPPL	86	Null	7
SUPPL	87	Null	30
SUPPL	97	Null	6
SUPPL	100	Null	7

CDER Filings

NOVARTIS PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125319
            [companyName] => NOVARTIS PHARMS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125319s100lbl.pdf#page=19"]
            [products] => [{"drugName":"ILARIS","activeIngredients":"CANAKINUMAB","strength":"180MG","dosageForm":"INJECTABLE; SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/18\/2020","submission":"SUPPL-100","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125319s100lbl.pdf\"}]","notes":""},{"actionDate":"06\/16\/2020","submission":"SUPPL-97","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125319s097lbl.pdf\"}]","notes":""},{"actionDate":"12\/22\/2016","submission":"SUPPL-88","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125319s088lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"09\/23\/2016","submission":"SUPPL-87","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2016","submission":"SUPPL-86","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2016","submission":"SUPPL-85","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2016","submission":"SUPPL-84","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125319s084lbl.pdf\"}]","notes":""},{"actionDate":"10\/16\/2014","submission":"SUPPL-81","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125319s081lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2013","submission":"SUPPL-62","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125319s062lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2012","submission":"SUPPL-54","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125319s0054.pdf\"}]","notes":""},{"actionDate":"03\/30\/2012","submission":"SUPPL-47","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125319s047lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125319s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/17\/2009","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/125319s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2009\\\/125319s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125319s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2009\\\/125319s000_SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/18\/2020","submission":"SUPPL-100","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125319s100lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125319Orig1s100ltr.pdf\"}]","notes":">"},{"actionDate":"06\/16\/2020","submission":"SUPPL-97","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125319s097lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125319Orig1s097ltr.pdf\"}]","notes":">"},{"actionDate":"12\/22\/2016","submission":"SUPPL-88","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125319s088lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125319Orig1s088ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2016","submission":"SUPPL-87","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125319Orig1s085,s086,s087ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125319Orig1s085,086,087TOC.cfm\"}]","notes":">"},{"actionDate":"09\/23\/2016","submission":"SUPPL-86","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125319Orig1s085,s086,s087ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125319Orig1s085,086,087TOC.cfm\"}]","notes":">"},{"actionDate":"09\/23\/2016","submission":"SUPPL-85","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/BLA125319_858687lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125319Orig1s085,s086,s087ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125319Orig1s085,086,087TOC.cfm\"}]","notes":">"},{"actionDate":"07\/21\/2016","submission":"SUPPL-84","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125319s084lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125319Orig1s084ltr.pdf\"}]","notes":">"},{"actionDate":"10\/16\/2014","submission":"SUPPL-81","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125319s081lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125319Orig1s081ltr.pdf\"}]","notes":">"},{"actionDate":"05\/09\/2013","submission":"SUPPL-62","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125319s062lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125319Orig1s062ltr_repl.pdf\"}]","notes":">"},{"actionDate":"10\/11\/2012","submission":"SUPPL-54","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125319s0054.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125319Orig1s054ltr.pdf\"}]","notes":">"},{"actionDate":"03\/30\/2012","submission":"SUPPL-47","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125319s047lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125319s047ltr.pdf\"}]","notes":">"},{"actionDate":"11\/17\/2011","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-09-18
        )

)

BLA 125319

NOVARTIS PHARMS

FDA Drug Application

Application #125319

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

NOVARTIS PHARMS