BLA 761078

EMD SERONO INC

FDA Drug Application

Application #761078

Documents

• Label: 2017-05-09
• Medication Guide: 2017-05-09
• Letter: 2017-05-09
• Review: 2018-06-08

Application Sponsors

BLA 761078

EMD SERONO INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

20MG/ML

2

BAVENCIO

AVELUMAB

FDA Submissions

TYPE 9- BLA; Type 9 - New indication submitted as distinct BLA, consolidated

ORIG

1

AP

2017-05-09

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

EMD SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761078
            [companyName] => EMD SERONO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761078s000lbl.pdf#page=23"]
            [products] => [{"drugName":"BAVENCIO","activeIngredients":"AVELUMAB","strength":"20MG\/ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761078s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761078s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761078Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761078Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-05-09
        )

)