EXONDYS 51 (ETEPLIRSEN)
Summary
FDA approved EXONDYS 51 (ETEPLIRSEN) by SAREPTA THERAPS INC. NDA (New Drug) approval (Labeling) on 2024-12-27. SOLUTION, INTRAVENOUS.
Details
Source
Drug Approval
External ID
NDA206488-35
Action Date
2024-12-27
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
EXONDYS 51 (generic: ETEPLIRSEN), SOLUTION, INTRAVENOUS. Application: NDA206488
Company
Context & Analysis
Frequently Asked Questions
How often does SAREPTA THERAPS INC have FDA actions?
This is the only FDA action we have on record for SAREPTA THERAPS INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA206488-35" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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