FDA Approval for EXONDYS 51 issued to SAREPTA THERAPS INC
$SRPT
Biotechnology: Pharmaceutical Preparations
Health Care
New Drug Application (NDA): 206488
Company: SAREPTA THERAPS INC
Company: SAREPTA THERAPS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXONDYS 51 | ETEPLIRSEN | 100MG/2ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
| EXONDYS 51 | ETEPLIRSEN | 500MG/10ML (50MG/ML) | SOLUTION;INTRAVENOUS | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/2016 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206488lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206488Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/206488_summary review_Redacted.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/18/2022 | SUPPL-29 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206488Orig1s027,s028,s029ltr.pdf |
| 01/18/2022 | SUPPL-28 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206488Orig1s027,s028,s029ltr.pdf |
| 01/18/2022 | SUPPL-27 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206334Orig1s007ltr.pdf |
| 07/07/2020 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206488s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/206488Orig1s019ltr.pdf | |
| 10/11/2018 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206488s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206488Orig1s009Ltr.pdf | |
| 02/08/2018 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206488s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206488Orig1s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/review/2018/206488Orig1s006.pdf | |
| 02/22/2017 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/07/2020 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/206488s019lbl.pdf | |
| 10/11/2018 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206488s009lbl.pdf | |
| 02/08/2018 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206488s006lbl.pdf | |
| 09/19/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206488lbl.pdf |