Documents
Application Sponsors
BLA 761125 | NOVARTIS PHARMS CORP | |
Marketing Status
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] => ["",""]
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[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
)
)