NDA 206192

GENENTECH INC

FDA Drug Application

Application #206192

Documents

• Letter: 2015-11-10
• Label: 2015-11-10
• Review: 2015-12-08
• Letter: 2016-06-01
• Label: 2016-06-01
• Summary Review: 2015-12-08
• Label: 2018-01-30
• Letter: 2018-01-30
• Letter: 2022-07-29
• Label: 2022-07-29
• Label: 2022-10-31
• Letter: 2022-10-31

Application Sponsors

NDA 206192

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 20MG BASE

1

COTELLIC

COBIMETINIB FUMARATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-11-10	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2018-01-26	STANDARD
EFFICACY; Efficacy	SUPPL	4	AP	2022-07-28	PRIORITY
EFFICACY; Efficacy	SUPPL	5	AP	2022-10-28	PRIORITY

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6
SUPPL	4	Null	7
SUPPL	5	Null	7

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206192
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"COTELLIC","activeIngredients":"COBIMETINIB FUMARATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/26\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206192s002lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206192s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/31\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206192s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206192s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/10\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/206192s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/206192Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206192Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/206192Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/26\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206192s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206192Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"05\/31\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206192s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206192Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2018-01-26
        )

)