BLA 761122

GLAXOSMITHKLINE

FDA Drug Application

Application #761122

Documents

• Label: 2019-06-07
• Letter: 2019-06-07
• Review: 2019-08-26
• Letter: 2019-09-13
• Letter: 2019-09-13
• Label: 2019-09-13
• Label: 2019-09-13
• Pediatric Other: 1900-01-01
• Label: 2020-09-25
• Letter: 2020-09-29
• Pediatric Medical Review: 1900-01-01
• Letter: 2021-08-02
• Label: 2021-08-02
• Letter: 2022-01-25
• Label: 2022-01-26

Application Sponsors

BLA 761122

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS

100MG/ML

0

NUCALA

MEPOLIZUMAB

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2019-06-06	STANDARD
LABELING; Labeling	SUPPL	2	AP	2019-09-12	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2019-09-12	STANDARD
LABELING; Labeling	SUPPL	5	AP	2020-09-25	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2021-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2022-01-22	N/A

Submissions Property Types

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

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761122
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUCALA","activeIngredients":"MEPOLIZUMAB","strength":"100MG\/ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2019","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761122s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/06\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761122s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761122Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761122Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/12\/2019","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125526Orig1s012,%20761122Orig1s002,s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-12
        )

)