NDA 022334

NOVARTIS

FDA Drug Application

Application #022334

Documents

• Letter: 2010-07-14
• Letter: 2010-11-04
• Letter: 2011-05-10
• Letter: 2012-07-23
• Letter: 2012-05-02
• Letter: 2012-08-31
• Letter: 2013-11-07
• Letter: 2014-07-03
• Letter: 2015-01-26
• Letter: 2015-05-26
• Letter: 2015-09-22
• Letter: 2016-02-01
• Letter: 2016-02-05
• Letter: 2016-02-23
• Letter: 2016-02-29
• Label: 2009-04-03
• Label: 2010-05-17
• Label: 2010-07-12
• Label: 2010-11-01
• Label: 2011-05-06
• Label: 2012-04-02
• Label: 2012-08-31
• Label: 2014-02-21
• Label: 2013-11-08
• Label: 2014-02-21
• Label: 2014-07-02
• Label: 2014-12-19
• Label: 2015-01-29
• Label: 2015-09-23
• Label: 2016-02-02
• Label: 2016-06-17
• Review: 2009-05-15
• Summary Review: 2009-05-15
• Letter: 2009-04-03
• Letter: 2010-05-18
• Letter: 2011-05-10
• Letter: 2012-04-02
• Letter: 2012-04-02
• Letter: 2014-02-21
• Letter: 2014-02-21
• Letter: 2014-02-21
• Letter: 2014-12-19
• Letter: 2016-06-16
• Label: 2011-05-06
• Label: 2012-04-02
• Label: 2012-07-20
• Label: 2012-04-26
• Label: 2014-02-21
• Label: 2015-05-27
• Label: 2016-02-11
• Label: 2016-02-26
• Review: 2013-10-21
• Label: 2017-09-28
• Letter: 2017-09-28
• Pediatric Written Request: 2010-04-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Label: 2018-04-11
• Letter: 2018-04-12
• Pediatric Medical Review: 1900-01-01
• Letter: 2020-01-23
• Label: 2020-01-23
• Label: 2020-02-14
• Letter: 2020-02-14
• Label: 2021-04-19
• Letter: 2021-04-19
• Label: 2022-01-20
• Letter: 2022-02-02
• Label: 2022-02-03

Application Sponsors

NDA 022334

NOVARTIS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	5MG	1	AFINITOR	EVEROLIMUS
002	TABLET;ORAL	10MG	1	AFINITOR	EVEROLIMUS
003	TABLET;ORAL	2.5MG	1	AFINITOR	EVEROLIMUS
004	TABLET;ORAL	7.5MG	1	AFINITOR	EVEROLIMUS

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2009-03-30	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2010-07-09	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2010-07-09	N/A
EFFICACY; Efficacy	SUPPL	6	AP	2010-10-29	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2011-05-05	PRIORITY
LABELING; Labeling	SUPPL	10	AP	2011-05-05	UNKNOWN
EFFICACY; Efficacy	SUPPL	14	AP	2012-03-30	STANDARD
LABELING; Labeling	SUPPL	15	AP	2012-03-30	UNKNOWN
EFFICACY; Efficacy	SUPPL	16	AP	2012-07-20	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2012-04-26	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2012-08-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2013-03-26	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2013-06-21	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2014-02-20	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2013-11-06	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-02-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2014-02-20	STANDARD
LABELING; Labeling	SUPPL	25	AP	2014-07-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	2014-09-12	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	2014-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2014-10-20	PRIORITY
LABELING; Labeling	SUPPL	29	AP	2015-01-23	STANDARD
EFFICACY; Efficacy	SUPPL	30	AP	2015-05-22	STANDARD
EFFICACY; Efficacy	SUPPL	31	AP	2015-09-18	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2016-01-29	STANDARD
LABELING; Labeling	SUPPL	34	AP	2016-02-04	STANDARD
EFFICACY; Efficacy	SUPPL	35	AP	2016-02-18	PRIORITY
EFFICACY; Efficacy	SUPPL	36	AP	2016-02-26	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2016-06-14	STANDARD
EFFICACY; Efficacy	SUPPL	39	AP	2017-09-26	STANDARD
EFFICACY; Efficacy	SUPPL	40	AP	2018-04-10	STANDARD
LABELING; Labeling	SUPPL	44	AP	2020-02-13	STANDARD
LABELING; Labeling	SUPPL	45	AP	2020-01-22	STANDARD
LABELING; Labeling	SUPPL	47	AP	2021-04-16	STANDARD
EFFICACY; Efficacy	SUPPL	50	AP	2021-12-30	STANDARD
LABELING; Labeling	SUPPL	51	AP	2022-02-01	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	6
SUPPL	6	Null	31
SUPPL	9	Null	7
SUPPL	10	Null	6
SUPPL	14	Null	6
SUPPL	15	Null	6
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	15
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	6
SUPPL	22	Null	6
SUPPL	23	Null	6
SUPPL	24	Null	7
SUPPL	25	Null	7
SUPPL	26	Null	0
SUPPL	27	Null	15
SUPPL	28	Null	0
SUPPL	29	Null	6
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	32	Null	7
SUPPL	34	Null	6
SUPPL	35	Null	7
SUPPL	36	Orphan	5
SUPPL	38	Null	7
SUPPL	39	Null	15
SUPPL	40	Null	6
SUPPL	44	Null	6
SUPPL	45	Null	7
SUPPL	47	Null	6
SUPPL	50	Null	15
SUPPL	51	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22334
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"AFINITOR","activeIngredients":"EVEROLIMUS","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"AFINITOR","activeIngredients":"EVEROLIMUS","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AFINITOR","activeIngredients":"EVEROLIMUS","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"AFINITOR","activeIngredients":"EVEROLIMUS","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/01\/2022","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/203985s023,022334s051lbl.pdf\"}]","notes":""},{"actionDate":"12\/30\/2021","submission":"SUPPL-50","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022334s050lbl.pdf\"}]","notes":""},{"actionDate":"04\/16\/2021","submission":"SUPPL-47","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/022334s047,203985s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2020","submission":"SUPPL-44","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022334s044,203985s016lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2020","submission":"SUPPL-44","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022334s044,203985s016lbl.pdf\"}]","notes":""},{"actionDate":"01\/22\/2020","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022334s045,203985s017lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/2018","submission":"SUPPL-40","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022334s040,203985s013lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2017","submission":"SUPPL-39","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022334s039lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2016","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022334s038lbl.pdf\"}]","notes":""},{"actionDate":"02\/26\/2016","submission":"SUPPL-36","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022334s036lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022334s034lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2016","submission":"SUPPL-34","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022334s034lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2016","submission":"SUPPL-32","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/022334s032,203985s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/18\/2015","submission":"SUPPL-31","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022334s031lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2015","submission":"SUPPL-30","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022334s030lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022334s029lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2014","submission":"SUPPL-27","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s027lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2014","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s025203985s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2014","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s021s023s024,203985s002s004s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s021s023s024,203985s002s004s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2014","submission":"SUPPL-23","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s021s023s024,203985s002s004s005lbl.pdf\"}]","notes":""},{"actionDate":"02\/20\/2014","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022334s021s023s024,203985s002s004s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/06\/2013","submission":"SUPPL-22","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022334s022lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2012","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022334s018lbl.pdf\"}]","notes":""},{"actionDate":"07\/20\/2012","submission":"SUPPL-16","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022334s016lbl.pdf\"}]","notes":""},{"actionDate":"04\/26\/2012","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022334s017lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2012","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022334s014s015.pdf\"}]","notes":""},{"actionDate":"03\/30\/2012","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022334s014s015.pdf\"}]","notes":""},{"actionDate":"05\/05\/2011","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022344s9s10lbl.pdf\"}]","notes":""},{"actionDate":"05\/05\/2011","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022344s9s10lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2010","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022334s6lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2010","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022334s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2010","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022334s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/30\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022334lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"AFINITOR","submission":"EVEROLIMUS","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AFINITOR","submission":"EVEROLIMUS","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AFINITOR","submission":"EVEROLIMUS","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"AFINITOR","submission":"EVEROLIMUS","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2022-02-01
        )

)