Documents
Application Sponsors
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 10MG/ML | 1 | BRIVIACT | BRIVARACETAM |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2016-02-18 | STANDARD FR Notice on DEA Scheduling; Date of Approval ? May 12, 2016 |
| EFFICACY; Efficacy | SUPPL | 2 | AP | 2017-09-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2018-05-10 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-08-27 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | TA | 2021-03-05 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 6 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 8 | Null | 4 |
CDER Filings
UCB INC
cder:Array
(
[0] => Array
(
[ApplNo] => 205838
[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\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"05\/10\/2018","submission":"SUPPL-3","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-2","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 3 - New Dosage Form","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-3","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-2","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
)
)