Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202834
Company: CATALYST PHARMS
Company: CATALYST PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FYCOMPA | PERAMPANEL | 2MG | TABLET;ORAL | Prescription | None | Yes | No |
FYCOMPA | PERAMPANEL | 4MG | TABLET;ORAL | Prescription | None | Yes | No |
FYCOMPA | PERAMPANEL | 6MG | TABLET;ORAL | Prescription | None | Yes | No |
FYCOMPA | PERAMPANEL | 8MG | TABLET;ORAL | Prescription | None | Yes | No |
FYCOMPA | PERAMPANEL | 10MG | TABLET;ORAL | Prescription | None | Yes | No |
FYCOMPA | PERAMPANEL | 12MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
10/22/2012 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202834Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202834Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/05/2023 | SUPPL-19 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202834Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202834Orig1s019ltr.pdf | |
10/26/2023 | SUPPL-18 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202834Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202834Orig1s018ltr.pdf | |
05/30/2019 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202834Orig1s016, 208277Orig1s004ltr.pdf | |
09/27/2018 | SUPPL-14 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202834Orig1s014,208277Orig1s002ltr.pdf | |
07/26/2017 | SUPPL-12 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202834Orig1s012,208277Orig1s001ltr.pdf | |
11/03/2016 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202834s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202834Orig1s011ltr.pdf | |
10/26/2016 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
12/23/2015 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/03/2015 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
12/14/2015 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/14/2014 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s006ltr.pdf | |
06/19/2015 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202834Orig1s005ltr.pdf | |
02/14/2014 | SUPPL-4 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s004ltr.pdf | |
02/24/2014 | SUPPL-3 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202834Orig1s003ltr.pdf |
09/02/2013 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/30/2013 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202834Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/05/2023 | SUPPL-19 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202834Orig1s019lbl.pdf | |
10/26/2023 | SUPPL-18 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202834Orig1s018lbl.pdf | |
05/30/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf | |
09/27/2018 | SUPPL-14 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf | |
07/26/2017 | SUPPL-12 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf | |
11/03/2016 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202834s011lbl.pdf | |
06/19/2015 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202834s005lbl.pdf | |
11/14/2014 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s006lbl.pdf | |
02/14/2014 | SUPPL-4 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf | |
02/14/2014 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf | |
06/30/2013 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202834s001lbl.pdf | |
10/22/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202834lbl.pdf |