Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022255
Company: UCB INC
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIMPAT | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | AA | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/20/2010 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022255s000,022254s003,022253s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255_vimpat_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022255Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/16/2023 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022253s057,022254s047,022255s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022253Orig1s057; 022254Orig1s047; 022255Orig1s039ltr.pdf | |
| 09/30/2022 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022253Orig1s055;022254Orig1s045;022255Orig1s037ltr.pdf | |
| 05/19/2022 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022254Orig1s044,022253Orig1s054,022255Orig1s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022254Orig1s044; 022253Orig1s054; 022255Orig1s036ltr.pdf | |
| 09/15/2021 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s051,022254s041,022255s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022253Orig1s051; 022254Orig1s041; 022255Orig1s033ltr.pdf | |
| 04/28/2023 | SUPPL-32 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022253s050,022254s040,022255s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022253Orig1s050;022254Orig1s040;022255Orig1s032ltr.pdf | |
| 10/14/2021 | SUPPL-31 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022253Orig1s049,022254Orig1s039,022255Orig1s031ltr.pdf | |
| 11/16/2020 | SUPPL-30 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022253s046s048,022254s036s038,022255s027s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022253Orig1s046, s048; 022254Orig1s036, s038; 022255Orig1s027, s030ltr.pdf | |
| 11/16/2020 | SUPPL-27 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022253s046s048,022254s036s038,022255s027s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022253Orig1s046, s048; 022254Orig1s036, s038; 022255Orig1s027, s030ltr.pdf | |
| 06/11/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022253s045,022254s035,022255s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022253Orig1s045;%20022254Orig1s035;%20022255Orig1s026ltr.pdf | |
| 11/11/2018 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022255s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022253Orig1s042,022254Orig1s033,022255Orig1s024ltr.pdf | |
| 01/09/2019 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022253s041,022254s032,022255s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022253Orig1s041,022254Orig1s032,022255Orig1s023ltr.pdf | |
| 11/03/2017 | SUPPL-22 | Efficacy-New Patient Population |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf | |
| 03/24/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s037,022254s029,022255s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022253Orig1s037,022254Orig1s029,022255Orig1s021ltr.pdf | |
| 02/26/2016 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/09/2015 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022253Orig1s030,022254Orig1s022,022255Orig1s016ltr.pdf | |
| 04/11/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/2014 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s028,022254Orig1s021,022255Orig1s014ltr.pdf | |
| 08/29/2014 | SUPPL-13 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf | |
| 08/29/2014 | SUPPL-12 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022253Orig1s026,s027,022254s019,s020,022255s012,s013ltr.pdf | |
| 01/17/2014 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2013 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s024,022254Orig1s018,022255Orig1s010ltr.pdf | |
| 01/16/2014 | SUPPL-9 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022255s009ltr.pdf022253Orig1s023,022254Orig1s015,022255Orig1s009ltr.pdf | |
| 02/05/2013 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s021,022254Orig1s014,022255Orig1s008ltr.pdf | |
| 08/10/2011 | SUPPL-7 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022253s020,022254s013,022255s007ltr.pdf |
| 09/25/2013 | SUPPL-5 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf | |
| 09/25/2013 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s014,s016,022254Orig1s008,s009,022255Orig1s003,s005ltr.pdf | |
| 02/08/2013 | SUPPL-2 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022253Orig1s010,022254Orig1s005,022255Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/16/2023 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022253s057,022254s047,022255s039lbl.pdf | |
| 04/28/2023 | SUPPL-32 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022253s050,022254s040,022255s032lbl.pdf | |
| 09/30/2022 | SUPPL-37 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf | |
| 09/30/2022 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022253s055,022254s045,022255s037lbl.pdf | |
| 05/19/2022 | SUPPL-36 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022254Orig1s044,022253Orig1s054,022255Orig1s036lbl.pdf | |
| 05/19/2022 | SUPPL-36 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022254Orig1s044,022253Orig1s054,022255Orig1s036lbl.pdf | |
| 05/19/2022 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022254Orig1s044,022253Orig1s054,022255Orig1s036lbl.pdf | |
| 10/14/2021 | SUPPL-31 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf | |
| 09/15/2021 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s051,022254s041,022255s033lbl.pdf | |
| 11/16/2020 | SUPPL-30 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022253s046s048,022254s036s038,022255s027s030lbl.pdf | |
| 11/16/2020 | SUPPL-27 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022253s046s048,022254s036s038,022255s027s030lbl.pdf | |
| 06/11/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022253s045,022254s035,022255s026lbl.pdf | |
| 01/09/2019 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022253s041,022254s032,022255s023lbl.pdf | |
| 11/11/2018 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022255s024lbl.pdf | |
| 11/03/2017 | SUPPL-22 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s039,022254s030,022255s022lbl.pdf | |
| 03/24/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022253s037,022254s029,022255s021lbl.pdf | |
| 07/09/2015 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022253s030,022254s022,022255s016lbl.pdf | |
| 08/29/2014 | SUPPL-13 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf | |
| 08/29/2014 | SUPPL-12 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022255s026s027,022254s019s020,022255s012s013lbl.pdf | |
| 08/12/2014 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s028,022254s021,022255s014lbl.pdf | |
| 01/16/2014 | SUPPL-9 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf | |
| 01/16/2014 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022253s023,022254s015,022255s009lbl.pdf | |
| 09/25/2013 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf | |
| 09/25/2013 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s014s016,022254s008s009,022255s003s005lbl.pdf | |
| 04/17/2013 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s024,022254s018,022255s010lbl.pdf | |
| 02/08/2013 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s010,022254s005,022255s002lbl.pdf | |
| 02/05/2013 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022253s021,022254s014,022255s008lbl.pdf | |
| 04/20/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022255lbl.pdf |
VIMPAT
SOLUTION;ORAL; 10MG/ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 214672 | ALKEM LABS LTD |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 204839 | AMNEAL PHARMS |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 206355 | APOTEX |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 209224 | AUROBINDO PHARMA LTD |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 209301 | HETERO LABS LTD III |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216461 | LEADING PHARMA |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 215379 | MSN |
| LACOSAMIDE | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | No | AA | 216151 | NOVITIUM PHARMA |
| VIMPAT | LACOSAMIDE | 10MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 022255 | UCB INC |