BLA 761068

ULTRAGENYX PHARM INC

FDA Drug Application

Application #761068

Documents

• Label: 2018-04-17
• Letter: 2018-04-17
• Review: 2018-05-15
• Letter: 2019-09-30
• Letter: 2019-10-01
• Label: 2019-10-01
• Label: 2019-10-07
• Letter: 2020-06-19
• Label: 2020-06-22

Application Sponsors

BLA 761068

ULTRAGENYX PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

2

CRYSVITA

BUROSUMAB-TWZA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2018-04-17	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2019-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2019-09-27	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2020-06-18	PRIORITY

Submissions Property Types

ORIG	1	Null	2
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	6

CDER Filings

ULTRAGENYX PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761068
            [companyName] => ULTRAGENYX PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CRYSVITA","activeIngredients":"BUROSUMAB-TWZA","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761068s005lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761068s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/27\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761068s003lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761068s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/17\/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\\\/761068s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761068Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/761068Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761068s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761068Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761068s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761068Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/27\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761068s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761068Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-18
        )

)