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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206488
Company: SAREPTA THERAPS INC

Summary Review

Products on NDA 206488

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206488

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.

Labels for NDA 206488

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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