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FDA NDA · NDA206488

EXONDYS 51

eteplirsen

Sponsor: SAREPTA THERAPS INC

APPLICATION
NDA206488
TYPE
NDA
ORIGINAL APPROVAL
2016-09-19
LATEST ACTION
2024-12-27
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

EXONDYS 51 · ReferencePrescription
ETEPLIRSEN 500MG/10ML (50MG/ML) · SOLUTION · INTRAVENOUS
EXONDYS 51 · ReferencePrescription
ETEPLIRSEN 100MG/2ML (50MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-12-27Labeling · Supplement 35 · standard — Label ↗AP
2022-01-18Labeling · Supplement 28 · standard — Letter ↗AP
2022-01-18Labeling · Supplement 29 · standard — Letter ↗AP
2022-01-18Labeling · Supplement 27 · standard — Letter ↗AP
2020-07-07Labeling · Supplement 19 · standard — Letter ↗AP
2018-10-11Labeling · Supplement 9 · standard — Label ↗AP
2018-02-08Labeling · Supplement 6 · standard — Label ↗AP
2017-02-22Labeling · Supplement 3 · standardAP
2016-09-19Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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