BLA 761061

JANSSEN BIOTECH

FDA Drug Application

Application #761061

Documents

• Label: 2017-07-13
• Letter: 2017-07-13
• Review: 2017-08-21
• Letter: 2019-01-29
• Label: 2019-01-29
• Letter: 2019-04-05
• Label: 2019-04-05
• Letter: 2019-11-26
• Label: 2019-11-29
• Medication Guide: 2019-11-29
• Label: 2020-06-02
• Medication Guide: 2020-06-02
• Letter: 2020-06-03
• Label: 2020-07-14
• Letter: 2020-07-17

Application Sponsors

BLA 761061

JANSSEN BIOTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

100MG/ML

0

TREMFYA

GUSELKUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-07-13	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2019-04-04	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2019-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2020-07-13	STANDARD
LABELING; Labeling	SUPPL	9	AP	2020-06-01	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6
SUPPL	4	Null	15
SUPPL	7	Null	6
SUPPL	9	Null	7

CDER Filings

JANSSEN BIOTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761061
            [companyName] => JANSSEN BIOTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761061s009lbl.pdf#page=15"]
            [products] => [{"drugName":"TREMFYA","activeIngredients":"GUSELKUMAB","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/01\/2020","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761061s009lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2019","submission":"SUPPL-4","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/04\/2019","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s002lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2019","submission":"SUPPL-1","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/13\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761061s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"07\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761061s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761061Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761061Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/01\/2020","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761061s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761061Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/22\/2019","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761061Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/04\/2019","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761061Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"01\/29\/2019","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761061s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761061Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-01
        )

)