NDA 022253

UCB INC

FDA Drug Application

Application #022253

Documents

• Letter: 2008-10-31
• Letter: 2010-01-20
• Letter: 2010-05-04
• Letter: 2013-02-12
• Letter: 2013-09-26
• Letter: 2013-04-23
• Letter: 2014-08-14
• Letter: 2015-07-13
• Label: 2008-10-29
• Label: 2012-08-28
• Label: 2013-09-27
• Label: 2013-02-06
• Label: 2014-09-03
• Label: 2015-07-13
• Review: 2008-12-17
• Letter: 2013-09-26
• Letter: 2011-08-12
• Letter: 2013-02-07
• Letter: 2014-01-17
• Letter: 2014-09-03
• Letter: 2014-09-03
• Label: 2009-11-20
• Label: 2013-02-12
• Label: 2013-09-27
• Label: 2014-01-17
• Label: 2013-04-19
• Label: 2014-09-03
• Label: 2014-08-19
• Summary Review: 2008-12-17
• Label: 2017-03-27
• Letter: 2017-03-29
• Label: 2017-11-07
• Label: 2018-11-23
• Letter: 2018-12-07
• Label: 2019-01-10
• Letter: 2019-02-13
• Label: 2019-06-12
• Medication Guide: 2019-06-12
• Letter: 2019-06-12
• Pediatric CDTL Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2020-11-16
• Label: 2020-11-16
• Medication Guide: 2020-11-16
• Medication Guide: 2020-11-16
• Letter: 2020-11-17
• Letter: 2020-11-17
• Letter: 2021-09-17
• Label: 2021-09-20
• Medication Guide: 2021-09-20
• Label: 2021-10-15
• Medication Guide: 2021-10-15
• Letter: 2021-10-19
• Letter: 2022-05-20
• Label: 2022-05-20
• Letter: 2022-05-20
• Letter: 2022-10-03
• Label: 2022-10-03
• Medication Guide: 2022-10-03

Application Sponsors

NDA 022253

UCB INC

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	1	VIMPAT	LACOSAMIDE
002	TABLET;ORAL	100MG	1	VIMPAT	LACOSAMIDE
003	TABLET;ORAL	150MG	1	VIMPAT	LACOSAMIDE
004	TABLET;ORAL	200MG	1	VIMPAT	LACOSAMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-10-28	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-11-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2010-04-20	UNKNOWN
LABELING; Labeling	SUPPL	10	AP	2013-02-08	STANDARD
LABELING; Labeling	SUPPL	14	AP	2013-09-25	STANDARD
LABELING; Labeling	SUPPL	16	AP	2013-09-25	UNKNOWN
REMS; REMS	SUPPL	20	AP	2011-08-10	N/A
LABELING; Labeling	SUPPL	21	AP	2013-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2012-12-03	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-01-16	UNKNOWN
LABELING; Labeling	SUPPL	24	AP	2013-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-10-11	STANDARD
EFFICACY; Efficacy	SUPPL	26	AP	2014-08-29	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2014-08-29	STANDARD
LABELING; Labeling	SUPPL	28	AP	2014-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2014-06-04	STANDARD
LABELING; Labeling	SUPPL	30	AP	2015-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2015-04-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2016-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2016-05-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2017-01-06	STANDARD
LABELING; Labeling	SUPPL	37	AP	2017-03-24	STANDARD
EFFICACY; Efficacy	SUPPL	39	AP	2017-11-03	STANDARD
EFFICACY; Efficacy	SUPPL	41	AP	2019-01-09	STANDARD
LABELING; Labeling	SUPPL	42	AP	2018-11-11	STANDARD
LABELING; Labeling	SUPPL	45	AP	2019-06-11	STANDARD
EFFICACY; Efficacy	SUPPL	46	AP	2020-11-16	STANDARD
EFFICACY; Efficacy	SUPPL	48	AP	2020-11-16	STANDARD
EFFICACY; Efficacy	SUPPL	49	AP	2021-10-14	STANDARD
LABELING; Labeling	SUPPL	51	AP	2021-09-15	STANDARD
LABELING; Labeling	SUPPL	53	AP	2022-05-19	STANDARD
LABELING; Labeling	SUPPL	54	AP	2022-05-19	STANDARD
LABELING; Labeling	SUPPL	55	AP	2022-09-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	6
SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	14	Null	6
SUPPL	16	Null	6
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	0
SUPPL	23	Null	15
SUPPL	24	Null	6
SUPPL	25	Null	0
SUPPL	26	Null	15
SUPPL	27	Null	6
SUPPL	28	Null	7
SUPPL	29	Null	0
SUPPL	30	Null	15
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	37	Null	15
SUPPL	39	Null	15
SUPPL	41	Null	15
SUPPL	42	Null	15
SUPPL	45	Null	7
SUPPL	46	Null	15
SUPPL	48	Null	15
SUPPL	49	Null	6
SUPPL	51	Null	6
SUPPL	54	Null	4
SUPPL	55	Null	7

TE Codes

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

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22253
            [companyName] => UCB INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/022253s045,022254s035,022255s026lbl.pdf#page=26"]
            [products] => [{"drugName":"VIMPAT","activeIngredients":"LACOSAMIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIMPAT","activeIngredients":"LACOSAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIMPAT","activeIngredients":"LACOSAMIDE","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"VIMPAT","activeIngredients":"LACOSAMIDE","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-45","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022253s045,022254s035,022255s026lbl.pdf\"}]","notes":""},{"actionDate":"01\/09\/2019","submission":"SUPPL-41","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/022253s041,022254s032,022255s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/11\/2018","submission":"SUPPL-42","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022253s042lbl.pdf\"}]","notes":""},{"actionDate":"11\/03\/2017","submission":"SUPPL-39","supplementCategories":"Efficacy-New Patient 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022253s004,022254s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2009","submission":"SUPPL-4","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022253s004,022254s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/28\/2008","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/022253lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIMPAT","submission":"LACOSAMIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIMPAT","submission":"LACOSAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIMPAT","submission":"LACOSAMIDE","actionType":"150MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"VIMPAT","submission":"LACOSAMIDE","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)