BLA 761049

EMD SERONO INC

FDA Drug Application

Application #761049

Documents

• Label: 2017-03-23
• Letter: 2017-03-24
• Letter: 2017-04-27
• Review: 2017-05-02
• Label: 2017-10-25
• Letter: 2017-10-30
• Letter: 2018-10-23
• Label: 2018-10-26
• Label: 2019-05-15
• Medication Guide: 2019-05-15
• Letter: 2019-05-15
• Label: 2020-07-01
• Medication Guide: 2020-07-01
• Letter: 2020-07-01
• Review: 2020-11-04
• Letter: 2020-11-12
• Label: 2020-11-13
• Medication Guide: 2020-11-13
• Letter: 2022-07-18
• Label: 2022-07-19
• Medication Guide: 2022-07-19

Application Sponsors

BLA 761049

EMD SERONO INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/ML

0

BAVENCIO

AVELUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-03-23	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2017-10-12	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2018-10-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-11-10	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2019-05-14	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2020-06-30	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	2022-07-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Orphan	5
SUPPL	3	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	6
SUPPL	9	Null	7
SUPPL	13	Null	6

CDER Filings

EMD SERONO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761049
            [companyName] => EMD SERONO INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761049s009lbl.pdf#page=36"]
            [products] => [{"drugName":"BAVENCIO","activeIngredients":"AVELUMAB","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761049s009lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761049s006lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761049s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/12\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761049s002lbl.pdf\"}]","notes":""},{"actionDate":"03\/23\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/23\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761049Orig1s000ltredt.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761049Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/30\/2020","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761049s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761049Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2019","submission":"SUPPL-6","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761049s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761049Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"10\/19\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761049s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761049Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/12\/2017","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761049s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761049Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/25\/2017","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761049Orig1s001ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-06-30
        )

)