EISAI INC FDA Approval NDA 202834

NDA 202834

EISAI INC

FDA Drug Application

Application #202834

Documents

Letter2012-10-26
Letter2013-07-03
Letter2014-02-19
Label2013-07-11
Label2014-02-19
Label2015-06-23
Label2014-11-20
Review2012-11-28
Letter2014-02-26
Letter2015-06-24
Letter2014-11-17
Label2012-10-26
Label2016-11-07
Letter2016-11-08
Letter2017-07-28
Label2017-07-28
Medication Guide2017-07-28
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2018-10-01
Label2018-10-03
Medication Guide2018-10-03
Medication Guide2019-05-31
Label2019-05-31
Letter2019-06-04
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric CDTL Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01

Application Sponsors

NDA 202834EISAI INC

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004
Prescription005
Prescription006

Application Products

001TABLET;ORAL2MG1FYCOMPAPERAMPANEL
002TABLET;ORAL4MG1FYCOMPAPERAMPANEL
003TABLET;ORAL6MG1FYCOMPAPERAMPANEL
004TABLET;ORAL8MG1FYCOMPAPERAMPANEL
005TABLET;ORAL10MG1FYCOMPAPERAMPANEL
006TABLET;ORAL12MG1FYCOMPAPERAMPANEL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2012-10-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2013-09-02STANDARD
LABELING; LabelingSUPPL3AP2014-02-24STANDARD
LABELING; LabelingSUPPL4AP2014-02-14STANDARD
EFFICACY; EfficacySUPPL5AP2015-06-19STANDARD
LABELING; LabelingSUPPL6AP2014-11-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2015-12-14STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2015-09-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2015-12-23STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2016-10-26UNKNOWN
LABELING; LabelingSUPPL11AP2016-11-03STANDARD
EFFICACY; EfficacySUPPL12AP2017-07-26STANDARD
EFFICACY; EfficacySUPPL14AP2018-09-27PRIORITY
LABELING; LabelingSUPPL16AP2019-05-30STANDARD

Submissions Property Types

ORIG1Null40
SUPPL2Null0
SUPPL3Null6
SUPPL4Null6
SUPPL5Null6
SUPPL6Null7
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL11Null7
SUPPL12Null7
SUPPL14Null7
SUPPL16Null7

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB
004PrescriptionAB
005PrescriptionAB
006PrescriptionAB

CDER Filings

EISAI INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202834
            [companyName] => EISAI INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/202834s016,208277s004lbl.pdf#page=24"]
            [products] => [{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"FYCOMPA","activeIngredients":"PERAMPANEL","strength":"12MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/30\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202834s016,208277s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202834s014,208277s002lbl.pdf\"}]","notes":""},{"actionDate":"07\/26\/2017","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202834s012,208277s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/03\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202834s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202834s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202834s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202834s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202834s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202834s001lbl.pdf\"}]","notes":""},{"actionDate":"10\/22\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202834lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/22\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202834lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202834Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/202834Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/30\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202834s016,208277s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/27\/2018","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202834s014,208277s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202834Orig1s014,208277Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"07\/26\/2017","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202834s012,208277s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202834Orig1s012,208277Orig1s001ltr.pdf\"}]","notes":">"},{"actionDate":"11\/03\/2016","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202834s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202834Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2016","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/23\/2015","submission":"SUPPL-9","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/03\/2015","submission":"SUPPL-8","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/14\/2015","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/14\/2014","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202834s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202834Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2015","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/202834s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/202834Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"02\/14\/2014","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202834s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202834Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/24\/2014","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202834Orig1s003ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/02\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202834s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202834Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-05-30
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.