Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 208277
Company: CATALYST PHARMS
Company: CATALYST PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FYCOMPA | PERAMPANEL | 0.5MG/ML | SUSPENSION;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 |
---|---|---|---|---|---|---|---|
04/29/2016 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208277s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208277Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208277Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/23/2023 | SUPPL-9 | Manufacturing (CMC)-Control |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208277Orig1s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208277Orig1s009ltr.pdf | |
02/23/2021 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208277Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208277Orig1s005ltr.pdf | |
05/30/2019 | SUPPL-4 | 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-2 | 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-1 | 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 |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
05/23/2023 | SUPPL-9 | Manufacturing (CMC)-Control | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208277Orig1s009lbl.pdf |
02/23/2021 | SUPPL-5 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208277Orig1s005lbl.pdf | |
05/30/2019 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202834s016,208277s004lbl.pdf | |
09/27/2018 | SUPPL-2 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202834s014,208277s002lbl.pdf | |
07/26/2017 | SUPPL-1 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202834s012,208277s001lbl.pdf | |
04/29/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208277s000lbl.pdf |