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New Drug Application (NDA): 206488
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 Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206488Orig1s027,s028,s029ltr.pdf
01/18/2022 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/206488Orig1s027,s028,s029ltr.pdf
01/18/2022 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf 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
01/18/2022 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf
01/18/2022 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf
01/18/2022 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/206488s027s028s029lbl.pdf
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
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