NOVARTIS FDA Approval NDA 021560

NDA 021560

NOVARTIS

FDA Drug Application

Application #021560

Documents

Letter2013-02-20
Letter2012-04-27
Letter2012-10-04
Letter2012-05-04
Letter2015-11-09
Label2013-02-20
Review2010-06-16
Summary Review2010-06-16
Letter2010-04-29
Letter2011-11-28
Letter2015-01-28
Label2010-05-03
Label2012-05-01
Label2012-10-04
Label2015-01-30
Label2015-11-12
Letter2016-10-14
Label2016-10-17
Letter2018-01-17
Label2018-01-17
Label2018-01-18
Medication Guide2018-01-18
Letter2020-08-12
Label2020-08-12
Medication Guide2020-08-12

Application Sponsors

NDA 021560NOVARTIS

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL0.25MG1ZORTRESSEVEROLIMUS
002TABLET;ORAL0.5MG1ZORTRESSEVEROLIMUS
003TABLET;ORAL0.75MG1ZORTRESSEVEROLIMUS
004TABLET;ORAL1MG1ZORTRESSEVEROLIMUS

FDA Submissions

TYPE 5; Type 5 - New Formulation or New ManufacturerORIG1AP2010-04-20STANDARD
REMS; REMSSUPPL4AP2011-11-21N/A
EFFICACY; EfficacySUPPL6AP2013-02-15STANDARD
LABELING; LabelingSUPPL7AP2012-04-26STANDARD
LABELING; LabelingSUPPL8AP2012-10-02STANDARD
REMS; REMSSUPPL9AP2012-05-02N/A
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2013-03-26STANDARD
LABELING; LabelingSUPPL11AP2015-01-27STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2013-12-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL13AP2013-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2015-06-24STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2016-03-01STANDARD
LABELING; LabelingSUPPL18AP2015-11-05901 ORDER
EFFICACY; EfficacySUPPL19AP2016-10-12STANDARD
LABELING; LabelingSUPPL20AP2018-01-12STANDARD
LABELING; LabelingSUPPL21AP2018-01-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2018-08-10STANDARD

Submissions Property Types

ORIG1Null40
SUPPL4Null7
SUPPL6Null7
SUPPL7Null7
SUPPL8Null15
SUPPL9Null6
SUPPL10Null0
SUPPL11Null15
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL17Null0
SUPPL18Null6
SUPPL19Null6
SUPPL20Null7
SUPPL21Null33

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21560
            [companyName] => NOVARTIS
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/021560Orig1s022lbl.pdf#page=31"]
            [products] => [{"drugName":"ZORTRESS","activeIngredients":"EVEROLIMUS","strength":"0.25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZORTRESS","activeIngredients":"EVEROLIMUS","strength":"0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZORTRESS","activeIngredients":"EVEROLIMUS","strength":"0.75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"ZORTRESS","activeIngredients":"EVEROLIMUS","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/10\/2018","submission":"SUPPL-22","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021560Orig1s022lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"01\/12\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021560s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021560s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/12\/2018","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021560s020lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2016","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021560s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/05\/2015","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021560s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2015","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021560s011lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2013","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021560s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/02\/2012","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021560s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021560s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021560s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZORTRESS","submission":"EVEROLIMUS","actionType":"0.25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZORTRESS","submission":"EVEROLIMUS","actionType":"0.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZORTRESS","submission":"EVEROLIMUS","actionType":"0.75MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZORTRESS","submission":"EVEROLIMUS","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-08-10
        )

)
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