OPZELURA (RUXOLITINIB)
Summary
FDA approved OPZELURA (RUXOLITINIB) by INCYTE CORP. NDA (New Drug) approval (Efficacy) on 2025-09-18. CREAM, TOPICAL.
Details
Source
Drug Approval
External ID
NDA215309-7
Action Date
2025-09-18
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
OPZELURA (generic: RUXOLITINIB), CREAM, TOPICAL. Application: NDA215309
Company
Context & Analysis
INCYTE CORP has 2 FDA actions in our database.
Frequently Asked Questions
How often does INCYTE CORP have FDA actions?
INCYTE CORP 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 "NDA215309-7" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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