BLA 125509

ELUSYS THERAPEUTICS INC

FDA Drug Application

Application #125509

Documents

• Letter: 2016-03-28
• Label: 2016-03-28
• Review: 2016-04-26
• Summary Review: 2016-04-26
• Label: 2017-10-30
• Pediatric Medical Review: 1900-01-01
• Pediatric Medical Addendum: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Addendum: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-11-29
• Letter: 2019-12-02

Application Sponsors

BLA 125509

ELUSYS THERAPEUTICS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

600MG/6ML

0

ANTHIM

OBILTOXAXIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-03-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-11-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	15	Null	15

CDER Filings

ELUSYS THERAPEUTICS INC

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(
    [0] => Array
        (
            [ApplNo] => 125509
            [companyName] => ELUSYS THERAPEUTICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANTHIM","activeIngredients":"OBILTOXAXIMAB","strength":"600MG\/6ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125509s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/20\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125509s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125509lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125509lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125509Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125509Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125509Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/29\/2019","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125509s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125509Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"10\/20\/2016","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125509s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2019-11-29
        )

)