ISTURISA (OSILODROSTAT)
Summary
FDA approved ISTURISA (OSILODROSTAT) by RECORDATI RARE. NDA (New Drug) approval (Manufacturing (CMC)) on 2025-11-04. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA212801-7
Action Date
2025-11-04
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ISTURISA (generic: OSILODROSTAT), TABLET, ORAL. Application: NDA212801
Company
Context & Analysis
RECORDATI RARE has 2 FDA actions in our database.
Frequently Asked Questions
How often does RECORDATI RARE have FDA actions?
RECORDATI RARE 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 "NDA212801-7" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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