NDA 208277

EISAI INC

FDA Drug Application

Application #208277

Documents

• Letter: 2016-05-06
• Label: 2016-05-03
• Letter: 2017-07-28
• Label: 2017-07-28
• Medication Guide: 2017-07-28
• Review: 2017-11-27
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Letter: 2018-10-01
• Label: 2018-10-03
• Medication Guide: 2018-10-03
• Label: 2019-05-31
• Medication Guide: 2019-05-31
• Letter: 2019-06-04
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01

Application Sponsors

NDA 208277

EISAI INC

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

0.5MG/ML

1

FYCOMPA

PERAMPANEL

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2016-04-29	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2018-09-27	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2019-05-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	6
SUPPL	4	Null	15

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208277
            [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":"0.5MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/30\/2019","submission":"SUPPL-4","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-2","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-1","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202834s012,208277s001lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208277s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/208277s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/208277Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/208277Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/30\/2019","submission":"SUPPL-4","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-2","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-1","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] => 2019-05-30
        )

)