BLA 761139

DAIICHI SANKYO

FDA Drug Application

Application #761139

Documents

• Label: 2019-12-20
• Letter: 2020-01-15
• Review: 2020-01-17
• Label: 2021-01-15
• Medication Guide: 2021-01-15
• Letter: 2021-04-09
• Label: 2022-05-04
• Label: 2022-05-04
• Medication Guide: 2022-05-04
• Letter: 2022-05-06
• Letter: 2022-05-06
• Letter: 2022-08-08
• Label: 2022-08-11
• Label: 2022-08-11
• Medication Guide: 2022-08-11
• Letter: 2022-08-12
• Label: 2022-11-07
• Letter: 2022-11-07

Application Sponsors

BLA 761139

DAIICHI SANKYO

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG

2

ENHERTU

FAM-TRASTUZUMAB DERUXTECAN-NXKI

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-12-20	PRIORITY
EFFICACY; Efficacy	SUPPL	11	AP	2021-01-15	PRIORITY
EFFICACY; Efficacy	SUPPL	17	AP	2022-05-04	PRIORITY
EFFICACY; Efficacy	SUPPL	20	AP	2022-05-04	PRIORITY
EFFICACY; Efficacy	SUPPL	21	AP	2022-08-11	PRIORITY
EFFICACY; Efficacy	SUPPL	22	AP	2022-08-05	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	2022-11-04	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	11	Null	7
SUPPL	17	Null	7
SUPPL	20	Null	7
SUPPL	21	Null	7
SUPPL	22	Null	6
SUPPL	24	Null	8

CDER Filings

DAIICHI SANKYO

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761139
            [companyName] => DAIICHI SANKYO
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENHERTU","activeIngredients":"FAM-TRASTUZUMAB DERUXTECAN-NXKI","strength":"100MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"12\/20\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761139s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/20\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761139s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761139Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761139Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-20
        )

)