BLA 761047

ULTRAGENYX PHARM INC

FDA Drug Application

Application #761047

Documents

• Letter: 2017-11-15
• Label: 2017-11-29
• Review: 2017-12-27
• Label: 2019-12-09
• Letter: 2019-12-10
• Label: 2020-12-28
• Letter: 2020-12-28

Application Sponsors

BLA 761047

ULTRAGENYX PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/5ML

0

MEPSEVII

VESTRONIDASE ALFA-VJBK

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-11-15	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2019-12-06	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2020-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	3	Null	6
SUPPL	5	Null	7

CDER Filings

ULTRAGENYX PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761047
            [companyName] => ULTRAGENYX PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MEPSEVII","activeIngredients":"VESTRONIDASE ALFA-VJBK","strength":"10MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761047s003lbl.pdf\"}]","notes":""},{"actionDate":"11\/15\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761047s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/15\/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\\\/761047s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761047Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761047Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/06\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761047s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761047Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-06
        )

)