NDA 213535

GENENTECH INC

FDA Drug Application

Application #213535

Documents

• Letter: 2020-08-03
• Label: 2020-08-10
• Review: 2020-09-04
• Letter: 2021-05-04
• Label: 2021-05-05
• Letter: 2022-05-31
• Letter: 2022-05-31
• Label: 2022-06-01
• Label: 2022-06-01
• Letter: 2022-09-22
• Label: 2022-09-23

Application Sponsors

NDA 213535

GENENTECH INC

Marketing Status

• Prescription: 001

Application Products

001

POWDER FOR ORAL SOLUTION

1.5MG

0

EVRYSDI

RISDIPLAM

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-08-07	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2022-05-27	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2022-05-27	PRIORITY
LABELING; Labeling	SUPPL	6	TA	2022-03-21	STANDARD

Submissions Property Types

ORIG	1	Null	10
SUPPL	3	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213535
            [companyName] => GENENTECH INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"EVRYSDI","activeIngredients":"RISDIPLAM","strength":"1.5MG","dosageForm":"POWDER FOR ORAL SOLUTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/07\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213535s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/07\/2020","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\\\/2020\\\/213535s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213535Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-08-07
        )

)