BLA 125349

HUMAN GENOME SCIENCES INC.

FDA Drug Application

Application #125349

Documents

• Letter: 2012-12-27
• Label: 2012-12-27
• Review: 2013-01-25
• Summary Review: 2013-01-25
• Label: 2018-01-17
• Letter: 2021-06-03
• Letter: 2021-06-03
• Label: 2021-06-03

Application Sponsors

BLA 125349

HUMAN GENOME SCIENCES INC.

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; IV (INFUSION)

1700MG/34ML (50MG/ML)

2

RAXIBACUMAB

RAXIBACUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-12-14	PRIORITY
EFFICACY; Efficacy	SUPPL	22	AP	2018-01-11	PRIORITY
LABELING; Labeling	SUPPL	26	AP	2021-06-02	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	22	Null	15
SUPPL	26	Null	7

CDER Filings

HUMAN GENOME SCIENCES INC.

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(
    [0] => Array
        (
            [ApplNo] => 125349
            [companyName] => HUMAN GENOME SCIENCES INC.
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAXIBACUMAB","activeIngredients":"RAXIBACUMAB","strength":"1700MG\/34ML (50MG\/ML)","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"01\/11\/2018","submission":"SUPPL-22","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125349s022lbl.pdf\"}]","notes":""},{"actionDate":"12\/14\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125349s000lbl.pdf\"}]","notes":""}]
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            [supplements] => [{"actionDate":"01\/11\/2018","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125349s022lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2018-01-11
        )

)