NDA 022416

SUNOVION PHARMS INC

FDA Drug Application

Application #022416

Documents

• Label: 2013-11-15
• Review: 2013-12-20
• Summary Review: 2013-12-20
• Letter: 2013-11-13
• Letter: 2015-09-01
• Label: 2015-08-28
• Letter: 2017-03-08
• Label: 2017-09-14
• Letter: 2017-09-20
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2019-03-18
• Label: 2019-03-18
• Medication Guide: 2019-03-18

Application Sponsors

NDA 022416

SUNOVION PHARMS INC

Marketing Status

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

Application Products

001	TABLET;ORAL	200MG	1	APTIOM	ESLICARBAZEPINE ACETATE
002	TABLET;ORAL	400MG	1	APTIOM	ESLICARBAZEPINE ACETATE
003	TABLET;ORAL	600MG	1	APTIOM	ESLICARBAZEPINE ACETATE
004	TABLET;ORAL	800MG	1	APTIOM	ESLICARBAZEPINE ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2013-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-06-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2015-09-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2016-01-06	STANDARD
LABELING; Labeling	SUPPL	6	AP	2017-03-07	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2017-09-13	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	2019-03-15	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	11	Null	6

TE Codes

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

CDER Filings

SUNOVION PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22416
            [companyName] => SUNOVION PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022416s011lbl.pdf#page=25"]
            [products] => [{"drugName":"APTIOM","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"APTIOM","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"400MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"APTIOM","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"600MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"APTIOM","activeIngredients":"ESLICARBAZEPINE ACETATE","strength":"800MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/15\/2019","submission":"SUPPL-11","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022416s011lbl.pdf\"}]","notes":""},{"actionDate":"09\/13\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022416s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2015","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022416s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022416s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"APTIOM","submission":"ESLICARBAZEPINE ACETATE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"APTIOM","submission":"ESLICARBAZEPINE ACETATE","actionType":"400MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"APTIOM","submission":"ESLICARBAZEPINE ACETATE","actionType":"600MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"APTIOM","submission":"ESLICARBAZEPINE ACETATE","actionType":"800MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-03-15
        )

)