GOMEKLI (MIRDAMETINIB)
Summary
FDA approved GOMEKLI (MIRDAMETINIB) by SPRINGWORKS. NDA (New Drug) approval (Type 3 - New Dosage Form) on 2025-02-11. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA219389-1
Action Date
2025-02-11
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
GOMEKLI (generic: MIRDAMETINIB), CAPSULE, ORAL. Application: NDA219389
Company
Context & Analysis
SPRINGWORKS has 2 FDA actions in our database.
Frequently Asked Questions
How often does SPRINGWORKS have FDA actions?
SPRINGWORKS has 2 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA219389-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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