Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 202834
Company: EISAI INC
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
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-Package Insert, Labeling-Container/Carton Labels 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202834s004lbl.pdf
02/14/2014 SUPPL-4 Labeling-Container/Carton Labels 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

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