Documents
Application Sponsors
| NDA 206488 | SAREPTA THERAPS INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | SOLUTION;INTRAVENOUS | 100MG/2ML (50MG/ML) | 1 | EXONDYS 51 | ETEPLIRSEN |
| 002 | SOLUTION;INTRAVENOUS | 500MG/10ML (50MG/ML) | 1 | EXONDYS 51 | ETEPLIRSEN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2016-09-19 | PRIORITY |
| LABELING; Labeling | SUPPL | 3 | AP | 2017-02-22 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-02-08 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-10-11 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2020-07-07 | STANDARD |
| LABELING; Labeling | SUPPL | 27 | AP | 2022-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 28 | AP | 2022-01-18 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2022-01-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Orphan | 5 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 19 | Null | 6 |
| SUPPL | 27 | Null | 7 |
| SUPPL | 28 | Null | 15 |
| SUPPL | 29 | Null | 6 |
CDER Filings
SAREPTA THERAPS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206488
[companyName] => SAREPTA THERAPS INC
[docInserts] => ["",""]
[products] => [{"drugName":"EXONDYS 51","activeIngredients":"ETEPLIRSEN","strength":"100MG\/2ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"EXONDYS 51","activeIngredients":"ETEPLIRSEN","strength":"500MG\/10ML (50MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"07\/07\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206488s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206488s009lbl.pdf\"}]","notes":""},{"actionDate":"02\/08\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206488s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/206488lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"09\/19\/2016","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\\\/2016\\\/206488lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/206488Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/206488_TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"\"}]","notes":">"}]
[supplements] => [{"actionDate":"07\/07\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/206488s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/206488Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"10\/11\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206488s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206488Orig1s009Ltr.pdf\"}]","notes":">"},{"actionDate":"02\/08\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/206488s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/206488Orig1s006ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/review\\\/2018\\\/206488Orig1s006.pdf\"}]","notes":">"},{"actionDate":"02\/22\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-07-07
)
)