BLA 125526

GLAXOSMITHKLINE LLC

FDA Drug Application

Application #125526

Documents

• Letter: 2015-11-05
• Review: 2015-12-11
• Summary Review: 2015-12-11
• Label: 2015-11-05
• Label: 2017-02-17
• Label: 2017-12-13
• Letter: 2017-12-18
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 2018-01-22
• Pediatric Clinical Pharmacology Addendum: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2019-06-07
• Letter: 2019-06-07
• Letter: 2019-09-13
• Label: 2019-09-13
• Pediatric Other: 1900-01-01
• Pediatric Other: 1900-01-01
• Label: 2020-09-28
• Letter: 2020-09-29
• Letter: 2021-08-02
• Label: 2021-08-02
• Letter: 2022-01-25
• Label: 2022-01-26

Application Sponsors

BLA 125526

GLAXOSMITHKLINE LLC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER

100MG

0

NUCALA

MEPOLIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-11-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-02-16	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2017-12-12	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	2019-09-12	STANDARD
LABELING; Labeling	SUPPL	13	AP	2019-06-06	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2020-09-25	PRIORITY
EFFICACY; Efficacy	SUPPL	18	AP	2021-07-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	2022-01-22	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	6
SUPPL	4	Null	15
SUPPL	12	Null	15
SUPPL	13	Null	6
SUPPL	17	Orphan	5
SUPPL	18	Null	7
SUPPL	19	Null	15

CDER Filings

GLAXOSMITHKLINE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125526
            [companyName] => GLAXOSMITHKLINE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUCALA","activeIngredients":"MEPOLIZUMAB","strength":"100MG","dosageForm":"INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/12\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/06\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s013lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2017","submission":"SUPPL-4","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125526s004lbl.pdf\"}]","notes":""},{"actionDate":"02\/16\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125526s002lbl.pdf\"}]","notes":""},{"actionDate":"11\/04\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125526Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/04\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125526Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125526Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125526Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125526Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/06\/2019","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125526Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"09\/12\/2019","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125526s012,761122s002s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/12\/2017","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125526s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125526Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"02\/16\/2017","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125526s002lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2019-09-12
        )

)