BLA 761079

BIOMARIN PHARM

FDA Drug Application

Application #761079

Documents

• Label: 2018-05-24
• Medication Guide: 2018-05-24
• Letter: 2018-05-25
• Review: 2018-06-28
• Letter: 2020-10-07
• Letter: 2020-10-07
• Letter: 2020-10-07
• Label: 2020-10-07
• Label: 2020-11-23
• Letter: 2020-11-25

Application Sponsors

BLA 761079

BIOMARIN PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	2.5MG/O.5ML	0	PALYNZIQ	PEGVALIASE-PQPZ
002	INJECTABLE;INJECTION	10MG/0.5ML	0	PALYNZIQ	PEGVALIASE-PQPZ
003	INJECTABLE;INJECTION	20MG/ML	0	PALYNZIQ	PEGVALIASE-PQPZ

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-05-24	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2020-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2020-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2020-10-06	STANDARD
LABELING; Labeling	SUPPL	10	AP	2020-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	5	Null	6
SUPPL	6	Orphan	5
SUPPL	7	Orphan	5
SUPPL	10	Null	7

CDER Filings

BIOMARIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761079
            [companyName] => BIOMARIN PHARM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/761079s000lbl.pdf#page=23"]
            [products] => [{"drugName":"PALYNZIQ","activeIngredients":"PEGVALIASE-PQPZ","strength":"2.5MG\/O.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PALYNZIQ","activeIngredients":"PEGVALIASE-PQPZ","strength":"10MG\/0.5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PALYNZIQ","activeIngredients":"PEGVALIASE-PQPZ","strength":"20MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761079s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/24\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761079s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761079Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761079Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-05-24
        )

)