EKTERLY (SEBETRALSTAT)
Summary
FDA approved EKTERLY (SEBETRALSTAT) by KALVISTA. NDA (New Drug) approval (Type 1 - New Molecular Entity) on 2025-07-03. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA219301-1
Action Date
2025-07-03
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
EKTERLY (generic: SEBETRALSTAT), TABLET, ORAL. Application: NDA219301
Company
Context & Analysis
Frequently Asked Questions
How often does KALVISTA have FDA actions?
This is the only FDA action we have on record for KALVISTA in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA219301-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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