BLA 761028

AMGEN INC

FDA Drug Application

Application #761028

Documents

• Label: 2017-09-14
• Letter: 2017-09-14
• Review: 2018-10-16
• Letter: 2019-06-25
• Label: 2019-06-27
• Label: 2021-04-20
• Letter: 2021-04-22
• Letter: 2021-11-16
• Label: 2021-11-16

Application Sponsors

BLA 761028

AMGEN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE; INJECTION	100MG/4ML (25MG/ML)	0	MVASI	BEVACIZUMAB-AWWB
002	INJECTABLE; INJECTION	400MG/16ML (25MG/ML)	0	MVASI	BEVACIZUMAB-AWWB

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2017-09-14	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2019-06-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	2021-04-19	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2021-11-15	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	6
SUPPL	6	Null	6
SUPPL	8	Null	15

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761028
            [companyName] => AMGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MVASI","activeIngredients":"BEVACIZUMAB-AWWB","strength":"100MG\/4ML (25MG\/ML)","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"MVASI","activeIngredients":"BEVACIZUMAB-AWWB","strength":"400MG\/16ML (25MG\/ML)","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/24\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-Accelerated Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761028s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/14\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761028s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761028s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761028Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761028Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/24\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761028s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761028Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-06-24
        )

)