UCB INC FDA Approval NDA 022255

NDA 022255

UCB INC

FDA Drug Application

Application #022255

Documents

Letter2010-05-04
Letter2013-02-12
Letter2013-09-26
Letter2013-02-07
Letter2014-01-17
Letter2013-04-23
Letter2014-08-14
Letter2015-07-13
Label2012-08-28
Label2013-02-12
Label2013-09-27
Label2013-02-06
Label2013-04-19
Label2014-09-03
Label2014-08-13
Label2015-07-13
Letter2013-09-26
Letter2011-08-12
Letter2014-09-03
Letter2014-09-03
Label2013-09-27
Label2014-01-17
Label2014-09-03
Review2010-12-01
Summary Review2011-02-17
Label2017-03-27
Letter2017-03-29
Label2017-11-07
Label2018-11-23
Letter2018-12-07
Label2019-01-10
Letter2019-02-13
Label2019-06-12
Medication Guide2019-06-12
Letter2019-06-12
Label2020-11-16
Medication Guide2020-11-16
Label2020-11-16
Medication Guide2020-11-16
Letter2020-11-17
Letter2020-11-17
Letter2021-09-17
Label2021-09-20
Medication Guide2021-09-20
Label2021-10-15
Medication Guide2021-10-15
Letter2021-10-19
Letter2022-05-20
Label2022-05-20
Letter2022-10-03
Label2022-10-03
Medication Guide2022-10-03

Application Sponsors

NDA 022255UCB INC

Marketing Status

Prescription001

Application Products

001SOLUTION;ORAL10MG/ML1VIMPATLACOSAMIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2010-04-20STANDARD
LABELING; LabelingSUPPL2AP2013-02-08STANDARD
LABELING; LabelingSUPPL3AP2013-09-25STANDARD
LABELING; LabelingSUPPL5AP2013-09-25STANDARD
REMS; REMSSUPPL7AP2011-08-10N/A
LABELING; LabelingSUPPL8AP2013-02-05STANDARD
LABELING; LabelingSUPPL9AP2014-01-16UNKNOWN
LABELING; LabelingSUPPL10AP2013-04-17STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2014-01-17STANDARD
EFFICACY; EfficacySUPPL12AP2014-08-29STANDARD
EFFICACY; EfficacySUPPL13AP2014-08-29STANDARD
LABELING; LabelingSUPPL14AP2014-08-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2014-04-11STANDARD
LABELING; LabelingSUPPL16AP2015-07-09STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2016-02-26STANDARD
LABELING; LabelingSUPPL21AP2017-03-24STANDARD
EFFICACY; EfficacySUPPL22AP2017-11-03STANDARD
EFFICACY; EfficacySUPPL23AP2019-01-09STANDARD
LABELING; LabelingSUPPL24AP2018-11-11STANDARD
LABELING; LabelingSUPPL26AP2019-06-11STANDARD
EFFICACY; EfficacySUPPL27AP2020-11-16STANDARD
EFFICACY; EfficacySUPPL30AP2020-11-16STANDARD
EFFICACY; EfficacySUPPL31AP2021-10-14STANDARD
LABELING; LabelingSUPPL33AP2021-09-15STANDARD
LABELING; LabelingSUPPL36AP2022-05-19STANDARD
LABELING; LabelingSUPPL37AP2022-09-30STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null6
SUPPL3Null6
SUPPL5Null7
SUPPL7Null6
SUPPL8Null6
SUPPL9Null7
SUPPL10Null7
SUPPL11Null0
SUPPL12Null15
SUPPL13Null6
SUPPL14Null7
SUPPL15Null0
SUPPL16Null15
SUPPL17Null0
SUPPL21Null6
SUPPL22Null7
SUPPL23Null7
SUPPL24Null15
SUPPL26Null7
SUPPL27Null15
SUPPL30Null7
SUPPL31Null7
SUPPL33Null15
SUPPL36Null15
SUPPL37Null6

TE Codes

001PrescriptionAA

CDER Filings

UCB INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22255
            [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":"10MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/11\/2019","submission":"SUPPL-26","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-23","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-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/022255s024lbl.pdf\"}]","notes":""},{"actionDate":"11\/03\/2017","submission":"SUPPL-22","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022253s039,022254s030,022255s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/24\/2017","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022253s037,022254s029,022255s021lbl.pdf\"}]","notes":""},{"actionDate":"07\/09\/2015","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022253s030,022254s022,022255s016lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2014","submission":"SUPPL-13","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022255s026s027,022254s019s020,022255s012s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2014","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022255s026s027,022254s019s020,022255s012s013lbl.pdf\"}]","notes":""},{"actionDate":"08\/12\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022253s028,022254s021,022255s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022253s023,022254s015,022255s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/16\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022253s023,022254s015,022255s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022253s014s016,022254s008s009,022255s003s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/25\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022253s014s016,022254s008s009,022255s003s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2013","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022253s024,022254s018,022255s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022253s010,022254s005,022255s002lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/2013","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022253s021,022254s014,022255s008lbl.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\\\/022255lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"VIMPAT","submission":"LACOSAMIDE","actionType":"10MG\/ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-06-11
        )

)
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