Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
| Prescription | 004 |
| Prescription | 005 |
Application Products
| 001 | TABLET;ORAL | 10MG | 1 | BRIVIACT | BRIVARACETAM |
| 002 | TABLET;ORAL | 25MG | 1 | BRIVIACT | BRIVARACETAM |
| 003 | TABLET;ORAL | 50MG | 1 | BRIVIACT | BRIVARACETAM |
| 004 | TABLET;ORAL | 75MG | 1 | BRIVIACT | BRIVARACETAM |
| 005 | TABLET;ORAL | 100MG | 1 | BRIVIACT | BRIVARACETAM |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2016-02-18 | STANDARD FR Notice on DEA Scheduling; Date of Approval ? May 12, 2016 |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2017-09-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 5 | AP | 2018-05-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 9 | AP | 2021-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | TA | 2021-03-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 11 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
| 004 | Prescription | AB |
| 005 | Prescription | AB |
CDER Filings
UCB INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205836
[companyName] => UCB INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/205836s005,205837s004,205838s003lbl.pdf#page=17"]
[products] => [{"drugName":"BRIVIACT","activeIngredients":"BRIVARACETAM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BRIVIACT","activeIngredients":"BRIVARACETAM","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BRIVIACT","activeIngredients":"BRIVARACETAM","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BRIVIACT","activeIngredients":"BRIVARACETAM","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BRIVIACT","activeIngredients":"BRIVARACETAM","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/10\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205836s005,205837s004,205838s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205836s003,205837s003,205838s002lbl.pdf\"}]","notes":""},{"actionDate":"06\/03\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205836s001,205837s001,205838s001lbl.pdf\"}]","notes":""},{"actionDate":"02\/18\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"02\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Federal Register Notice\",\"url\":\"https:\\\/\\\/www.federalregister.gov\\\/documents\\\/2016\\\/05\\\/12\\\/2016-11245\\\/schedules-of-controlled-substances-placement-of-brivaracetam-into-schedule-v\"},{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205836Orig1s000,205837Orig1s000,205838Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/0205836Orig1s000,0205837Orig1s000,0205838Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/205836-205837-205838-Briviact-TOC.cfm\"}]","notes":"> $(document).ready(function(){ $('[data-toggle=\"popover\"]').popover({ placement : 'top', trigger : 'hover' }); }); FR Notice on DEA Scheduling; Date of Approval \u2013 May 12, 2016"}]
[supplements] => [{"actionDate":"05\/10\/2018","submission":"SUPPL-5","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/205836s005,205837s004,205838s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/205836Orig1s005,205837Orig1s004,205838Orig1s003ltr(2).pdf\"}]","notes":">"},{"actionDate":"09\/14\/2017","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205836s003,205837s003,205838s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205836s003,205837s003,205838s002ltr.pdf\"}]","notes":">"},{"actionDate":"06\/03\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205836s001,205837s001,205838s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205836Orig1s001,205837Orig1s001,205838Orig1s001ltr.pdf\"}]","notes":">"}]
[actionDate] => 2018-05-10
)
)