BLA 761070

ASTRAZENECA AB

FDA Drug Application

Application #761070

Documents

• Label: 2017-11-15
• Letter: 2017-11-15
• Review: 2017-12-29
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-10-04
• Letter: 2019-10-04

Application Sponsors

BLA 761070

ASTRAZENECA AB

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

30MG/ML

2

FASENRA

BENRALIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-11-14	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2019-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	5	Null	7

CDER Filings

ASTRAZENECA AB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761070
            [companyName] => ASTRAZENECA AB
            [docInserts] => ["",""]
            [products] => [{"drugName":"FASENRA","activeIngredients":"BENRALIZUMAB","strength":"30MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"10\/03\/2019","submission":"SUPPL-5","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761070s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761070s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/03\/2019","submission":"SUPPL-5","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761070s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/14\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761070s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/14\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761070s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761070Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761070Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/03\/2019","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761070s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761070Orig1s005ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-10-03
        )

)