BLA 761052

BIOMARIN PHARM

FDA Drug Application

Application #761052

Documents

• Label: 2017-04-28
• Letter: 2017-04-28
• Review: 2017-06-07
• Label: 2018-12-12
• Letter: 2018-12-20
• Label: 2019-12-09
• Letter: 2019-12-10
• Letter: 2020-03-30
• Label: 2020-03-31

Application Sponsors

BLA 761052

BIOMARIN PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

30MG/ML

0

BRINEURA

CERLIPONASE ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-04-27	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2018-12-11	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-12-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-03-27	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	7
SUPPL	7	Null	6
SUPPL	8	Null	6

CDER Filings

BIOMARIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761052
            [companyName] => BIOMARIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"BRINEURA","activeIngredients":"CERLIPONASE ALFA","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761052s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761052s007lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761052s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/27\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761052lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/27\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761052Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761052Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/27\/2020","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761052s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761052Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"12\/06\/2019","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761052s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761052Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"12\/11\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761052s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761052Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-27
        )

)