NOVARTIS FDA Approval NDA 022527

NDA 022527

NOVARTIS

FDA Drug Application

Application #022527

Documents

Letter2010-09-27
Letter2011-07-25
Letter2012-03-05
Letter2012-05-11
Letter2015-05-04
Letter2015-05-19
Letter2015-07-10
Letter2016-02-23
Label2010-09-23
Label2014-05-02
Label2015-07-06
Label2016-02-23
Label2015-08-06
Review2010-11-12
Letter2012-03-20
Letter2014-05-01
Letter2013-05-29
Letter2015-08-06
Label2011-07-25
Label2011-07-06
Label2012-03-20
Label2012-05-10
Label2015-05-04
Other Important Information from FDA2011-12-21
Summary Review2011-02-17
Letter2016-12-01
Letter2017-12-20
Label2017-12-22
Label2018-05-11
Letter2018-05-15
Label2018-10-30
Label2019-01-14
Letter2019-01-18
Letter2019-09-20
Letter2019-09-20
Label2019-08-21
Label2019-08-21
Medication Guide2019-08-21
Medication Guide2019-08-21
Letter2019-12-27
Label2020-01-02
Pediatric CDTL Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Written Request1900-01-01

Application Sponsors

NDA 022527NOVARTIS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORALEQ 0.5MG BASE1GILENYAFINGOLIMOD HYDROCHLORIDE
002CAPSULE;ORALEQ 0.25MG BASE1GILENYAFINGOLIMOD HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2010-09-21PRIORITY
EFFICACY; EfficacySUPPL2AP2011-07-20STANDARD
LABELING; LabelingSUPPL3AP2011-07-01UNKNOWN
REMS; REMSSUPPL5AP2012-03-01N/A
LABELING; LabelingSUPPL6AP2012-03-18UNKNOWN
LABELING; LabelingSUPPL8AP2012-05-09STANDARD
LABELING; LabelingSUPPL9AP2014-04-30STANDARD
REMS; REMSSUPPL10AP2013-05-28N/A
LABELING; LabelingSUPPL13AP2015-05-01STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2014-08-22PRIORITY
REMS; REMSSUPPL15AP2015-05-14N/A
LABELING; LabelingSUPPL16AP2015-07-02STANDARD
LABELING; LabelingSUPPL18AP2016-02-19STANDARD
LABELING; LabelingSUPPL19AP2015-08-04STANDARD
REMS; REMSSUPPL21AP2016-11-29N/A
LABELING; LabelingSUPPL22AP2017-12-15STANDARD
EFFICACY; EfficacySUPPL24AP2018-05-11PRIORITY
LABELING; LabelingSUPPL26AP2019-01-11STANDARD
LABELING; LabelingSUPPL27AP2018-10-26STANDARD
LABELING; LabelingSUPPL29AP2019-08-16STANDARD
LABELING; LabelingSUPPL30AP2019-08-16STANDARD
LABELING; LabelingSUPPL31AP2019-12-26STANDARD

Submissions Property Types

ORIG1Null2
SUPPL2Null7
SUPPL3Null7
SUPPL5Null7
SUPPL6Null15
SUPPL8Null7
SUPPL9Null15
SUPPL10Null6
SUPPL13Null7
SUPPL14Null0
SUPPL15Null6
SUPPL16Null6
SUPPL18Null15
SUPPL19Null6
SUPPL21Null15
SUPPL22Null6
SUPPL24Null6
SUPPL26Null15
SUPPL27Null6
SUPPL29Null15
SUPPL30Null6
SUPPL31Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22527
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022527s029s030lbl.pdf#page=26"]
            [products] => [{"drugName":"GILENYA","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.5MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GILENYA","activeIngredients":"FINGOLIMOD HYDROCHLORIDE","strength":"EQ 0.25MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/26\/2019","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s031lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s029s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2019","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s029s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s029s030lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s029s030lbl.pdf\"}]","notes":""},{"actionDate":"01\/11\/2019","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022527s26lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022527s027lbl.pdf\"}]","notes":""},{"actionDate":"05\/11\/2018","submission":"SUPPL-24","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022527s024lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022527s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022527s018lbl.pdf\"}]","notes":""},{"actionDate":"02\/19\/2016","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022527s018lbl.pdf\"}]","notes":""},{"actionDate":"08\/04\/2015","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022527s019lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022527s016lbl.pdf\"}]","notes":""},{"actionDate":"05\/01\/2015","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022527s013lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022527s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/09\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022527s008lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022527s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2011","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022527s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2011","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022527s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022527s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GILENYA","submission":"FINGOLIMOD HYDROCHLORIDE","actionType":"EQ 0.5MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GILENYA","submission":"FINGOLIMOD HYDROCHLORIDE","actionType":"EQ 0.25MG BASE","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-12-26
        )

)
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