BLA 761158

GLAXOSMITHKLINE

FDA Drug Application

Application #761158

Documents

• Label: 2020-08-06
• Medication Guide: 2020-08-06
• Letter: 2020-08-10
• Review: 2020-09-01
• Letter: 2020-11-25
• Letter: 2021-12-08
• Letter: 2022-03-01
• Label: 2022-03-01
• Medication Guide: 2022-03-01

Application Sponsors

BLA 761158

GLAXOSMITHKLINE

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVENOUS

2.5MG/KG

0

BLENREP

BELANTAMAB MAFODOTIN-BLMF

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-05	PRIORITY
REMS; REMS	SUPPL	3	AP	2020-11-20	N/A
LABELING; Labeling	SUPPL	6	AP	2022-02-28	STANDARD
REMS; REMS	SUPPL	7	AP	2021-12-07	N/A

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	6	Null	6
SUPPL	7	Null	15

CDER Filings

GLAXOSMITHKLINE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761158
            [companyName] => GLAXOSMITHKLINE
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761158s000lbl.pdf#page=21"]
            [products] => [{"drugName":"BLENREP","activeIngredients":"BELANTAMAB MAFODOTIN-BLMF","strength":"2.5MG\/KG","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761158s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/05\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761158s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761158Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-05
        )

)