NDA 211970

SAREPTA THERAPS INC

FDA Drug Application

Application #211970

Documents

• Letter: 2019-12-13
• Label: 2019-12-13
• Review: 2020-01-21
• Letter: 2021-02-16
• Label: 2021-02-16

Application Sponsors

NDA 211970

SAREPTA THERAPS INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

100MG/2ML (50MG/ML)

1

VYONDYS 53

GOLODIRSEN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-12-12	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2021-02-11	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	6

CDER Filings

SAREPTA THERAPS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211970
            [companyName] => SAREPTA THERAPS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYONDYS 53","activeIngredients":"GOLODIRSEN","strength":"100MG\/2ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"02\/11\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211970s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/12\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211970s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/12\/2019","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\\\/2019\\\/211970s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211970Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211970Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"02\/11\/2021","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/211970s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/211970Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-02-11
        )

)