MODEYSO (DORDAVIPRONE)
Summary
FDA approved MODEYSO (DORDAVIPRONE) by CHIMERIX. NDA (New Drug) approval (Type 1 - New Molecular Entity) on 2025-08-06. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA219876-1
Action Date
2025-08-06
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
MODEYSO (generic: DORDAVIPRONE), CAPSULE, ORAL. Application: NDA219876
Company
Context & Analysis
Frequently Asked Questions
How often does CHIMERIX have FDA actions?
This is the only FDA action we have on record for CHIMERIX in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA219876-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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