OPSUMIT (MACITENTAN)
Summary
FDA approved OPSUMIT (MACITENTAN) by ACTELION. NDA (New Drug) approval (REMS) on 2025-04-02. TABLET, ORAL.
Details
Source
Drug Approval
External ID
NDA204410-31
Action Date
2025-04-02
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OPSUMIT (generic: MACITENTAN), TABLET, ORAL. Application: NDA204410
Company
Context & Analysis
ACTELION has 2 FDA actions in our database.
Frequently Asked Questions
How often does ACTELION have FDA actions?
ACTELION 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 "NDA204410-31" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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