BLA 761125

NOVARTIS PHARMS CORP

FDA Drug Application

Application #761125

Documents

• Label: 2019-10-08
• Letter: 2019-10-09
• Review: 2019-11-04
• Letter: 2020-06-10
• Label: 2020-06-12
• Review: 2020-10-06
• Label: 2022-02-22
• Label: 2022-02-22
• Label: 2022-02-22
• Letter: 2022-02-22
• Letter: 2022-02-22
• Letter: 2022-02-22
• Letter: 2022-05-31
• Label: 2022-05-31
• Label: 2022-12-21
• Letter: 2022-12-21

Application Sponsors

BLA 761125

NOVARTIS PHARMS CORP

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INTRAVITREAL

6MG/0.05ML

0

BEOVU

brolucizumab-dbll

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-10-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2022-03-09	N/A
LABELING; Labeling	SUPPL	4	AP	2020-06-09	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2022-05-27	STANDARD
LABELING; Labeling	SUPPL	10	AP	2022-02-18	STANDARD
LABELING; Labeling	SUPPL	12	AP	2022-02-18	STANDARD
LABELING; Labeling	SUPPL	13	AP	2022-02-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2022-12-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	4	Null	6
SUPPL	8	Null	7
SUPPL	10	Null	6
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	17	Null	6

CDER Filings

NOVARTIS PHARMS CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761125
            [companyName] => NOVARTIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEOVU","activeIngredients":"brolucizumab-dbll","strength":"6MG\/0.05ML","dosageForm":"INJECTABLE; INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761125s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761125Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761125_Orig1_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761125s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761125Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-09
        )

)