NDA 203415

ASTELLAS

FDA Drug Application

Application #203415

Documents

• Letter: 2014-09-16
• Letter: 2015-07-22
• Letter: 2015-10-09
• Label: 2012-08-31
• Label: 2013-03-26
• Label: 2015-09-21
• Label: 2015-10-08
• Letter: 2012-09-05
• Letter: 2015-08-10
• Label: 2014-09-10
• Label: 2015-07-22
• Review: 2012-09-12
• Summary Review: 2012-09-12
• Label: 2016-10-20
• Letter: 2016-10-21
• Label: 2017-07-25
• Letter: 2017-07-27
• Label: 2018-07-13
• Letter: 2018-07-16
• Label: 2019-12-16
• Letter: 2019-12-19
• Letter: 2020-10-27
• Label: 2020-10-27
• Letter: 2022-01-18
• Label: 2022-01-19
• Letter: 2022-09-12
• Label: 2022-09-13

Application Sponsors

NDA 203415

ASTELLAS

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

40MG

1

XTANDI

ENZALUTAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-08-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2014-05-23	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2014-09-10	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2015-07-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-08-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-10-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2015-11-06	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2016-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2016-07-14	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	2017-07-24	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2018-07-13	PRIORITY
EFFICACY; Efficacy	SUPPL	15	AP	2019-12-16	PRIORITY
EFFICACY; Efficacy	SUPPL	16	AP	2020-10-23	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2022-01-13	STANDARD
EFFICACY; Efficacy	SUPPL	19	AP	2022-09-09	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	7	Null	7
SUPPL	8	Null	0
SUPPL	9	Null	15
SUPPL	10	Null	0
SUPPL	11	Null	6
SUPPL	14	Null	15
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	18	Null	15
SUPPL	19	Null	6

TE Codes

001

Prescription

AB

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203415
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"XTANDI","activeIngredients":"ENZALUTAMIDE","strength":"40MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203415s015lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203415Orig1s014lbl.pdf\"}]","notes":""},{"actionDate":"07\/24\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203415s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2016","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203415s009lbl.pdf\"}]","notes":""},{"actionDate":"10\/01\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/05\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/21\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/10\/2014","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203415s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/19\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203415s001lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/31\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203415lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/31\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203415lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203415Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203415_xtandi_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203415Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/16\/2019","submission":"SUPPL-15","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203415s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203415Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"07\/13\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/203415Orig1s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/203415Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"07\/24\/2017","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203415s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203415Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"07\/14\/2016","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/20\/2016","submission":"SUPPL-9","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203415s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203415Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/06\/2015","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/01\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203415Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"08\/05\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203415Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/21\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203415s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203415Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/10\/2014","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/203415s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/203415Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"05\/23\/2014","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/19\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/203415s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-16
        )

)