BLA 103767

EISAI INC

FDA Drug Application

Application #103767

Documents

• Label: 2004-03-25
• Label: 2011-09-02
• Review: 2004-03-25
• Letter: 2004-03-25
• Letter: 2008-10-23
• Label: 2008-10-28
• Label: 2019-02-19
• Letter: 2019-02-21
• Label: 2020-02-11
• Letter: 2020-02-11

Application Sponsors

BLA 103767

EISAI INC

Marketing Status

• Prescription: 001

Application Products

001

VIAL

150UG/ML

0

ONTAK

DENILEUKIN DIFTITOX

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-02-05	PRIORITY
EFFICACY; Efficacy	SUPPL	5094	AP	2008-10-15	PRIORITY
LABELING; Labeling	SUPPL	5118	AP	2010-03-05	STANDARD
S; Supplement	SUPPL	5119	AP	2011-08-30
LABELING; Labeling	SUPPL	5143	AP	2019-02-15	STANDARD
LABELING; Labeling	SUPPL	5144	AP	2020-02-10	STANDARD

Submissions Property Types

ORIG	1	Null	27
SUPPL	5094	Orphan	5
SUPPL	5119	Null	0
SUPPL	5143	Null	15
SUPPL	5144	Null	6

CDER Filings

EISAI INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103767
            [companyName] => EISAI INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ONTAK","activeIngredients":"DENILEUKIN DIFTITOX","strength":"150UG\/ML","dosageForm":"VIAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/10\/2020","submission":"SUPPL-5144","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103767s5144lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-5143","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103767s5143lbl.pdf\"}]","notes":""},{"actionDate":"08\/30\/2011","submission":"SUPPL-5119","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103767s5119lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2008","submission":"SUPPL-5094","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103767s5094lbl.pdf\"}]","notes":""},{"actionDate":"02\/05\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/denser020599lb.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/05\/1999","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/denser020599lb.pdf\"},{\"name\":\"Letter\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/1999\\\/denser020599L.htm\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/web.archive.org\\\/web\\\/20120303004301\\\/https:\\\/\\\/www.fda.gov\\\/Drugs\\\/DevelopmentApprovalProcess\\\/HowDrugsareDevelopedandApproved\\\/ApprovalApplications\\\/TherapeuticBiologicApplications\\\/ucm080717.htm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/10\/2020","submission":"SUPPL-5144","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/103767s5144lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/103767Orig1s5144ltr.pdf\"}]","notes":">"},{"actionDate":"02\/15\/2019","submission":"SUPPL-5143","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/103767s5143lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/103767Orig1s5143ltr.pdf\"}]","notes":">"},{"actionDate":"08\/30\/2011","submission":"SUPPL-5119","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/103767s5119lbl.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2010","submission":"SUPPL-5118","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/15\/2008","submission":"SUPPL-5094","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/103767s5094lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/103767s5094ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-02-10
        )

)