NDA 203388

GENENTECH

FDA Drug Application

Application #203388

Documents

• Letter: 2012-01-31
• Letter: 2015-05-22
• Letter: 2015-05-22
• Label: 2012-01-30
• Label: 2015-05-27
• Label: 2015-05-27
• Review: 2012-03-02
• Letter: 2015-05-22
• Letter: 2015-05-22
• Label: 2015-05-27
• Label: 2015-05-27
• Letter: 2016-11-08
• Label: 2016-11-04
• Label: 2017-08-04
• Medication Guide: 2017-08-04
• Letter: 2017-08-04
• Label: 2019-01-22
• Medication Guide: 2019-01-22
• Letter: 2019-01-22
• Label: 2019-03-27
• Medication Guide: 2019-03-27
• Letter: 2019-03-28
• Letter: 2020-08-03
• Label: 2020-08-03
• Medication Guide: 2020-08-03

Application Sponsors

NDA 203388

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

150MG

1

ERIVEDGE

VISMODEGIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-01-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2013-06-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2013-12-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2014-10-15	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2015-05-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2015-05-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	2015-05-21	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-05-21	STANDARD
LABELING; Labeling	SUPPL	10	AP	2016-11-02	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-08-01	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2019-01-18	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-03-26	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-07-31	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	15
SUPPL	6	Null	15
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	10	Null	7
SUPPL	11	Null	7
SUPPL	12	Null	7
SUPPL	14	Null	7
SUPPL	16	Null	7

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203388
            [companyName] => GENENTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/203388s016lbl.pdf#page=14"]
            [products] => [{"drugName":"ERIVEDGE","activeIngredients":"VISMODEGIB","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203388s016lbl.pdf\"}]","notes":""},{"actionDate":"03\/26\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203388s014lbl.pdf\"}]","notes":""},{"actionDate":"01\/18\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203388s012lbl.pdf\"}]","notes":""},{"actionDate":"08\/01\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203388s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203388s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/02\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203388s010lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"05\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203388lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/30\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/203388lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/203388s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/203388Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/31\/2020","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/203388s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/203388Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"03\/26\/2019","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203388s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203388Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"01\/18\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/203388s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/203388Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"08\/01\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/203388s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/203388Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"11\/02\/2016","submission":"SUPPL-10","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/203388s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203388Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2015","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203388Orig1s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203388Orig1s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2015","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203388Orig1s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/21\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/203388s005s006s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/203388Orig1s005,s006,s007,s008ltr.pdf\"}]","notes":">"},{"actionDate":"10\/15\/2014","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/19\/2013","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/03\/2013","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/08\/2013","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-31
        )

)