BLA 761115

IMMUNOMEDICS INC

FDA Drug Application

Application #761115

Documents

• Label: 2020-04-22
• Letter: 2020-04-23
• Review: 2020-05-19
• Letter: 2021-04-09
• Letter: 2021-04-09
• Label: 2021-04-12
• Label: 2021-04-12
• Label: 2021-04-14
• Letter: 2021-04-14
• Letter: 2022-06-06
• Label: 2022-06-08
• Letter: 2022-12-06
• Label: 2022-12-07

Application Sponsors

BLA 761115

IMMUNOMEDICS INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

180MG

2

TRODELVY

SACITUZUMAB GOVITECAN-HZIY

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-04-22	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2021-04-07	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2021-04-13	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	2021-04-07	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2022-06-03	STANDARD
LABELING; Labeling	SUPPL	31	AP	2022-06-30	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	5	Null	7
SUPPL	9	Null	2
SUPPL	13	Null	6
SUPPL	23	Null	15

CDER Filings

IMMUNOMEDICS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761115
            [companyName] => IMMUNOMEDICS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRODELVY","activeIngredients":"SACITUZUMAB GOVITECAN-HZIY","strength":"180MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761115s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761115s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761115Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761115Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-22
        )

)