← FDA DRUG APPROVALS

FDA NDA · NDA216956

VELSIPITY

etrasimod

Sponsor: PFIZER

APPLICATION
NDA216956
TYPE
NDA
ORIGINAL APPROVAL
2023-10-12
LATEST ACTION
2025-08-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VELSIPITY · ReferencePrescription
ETRASIMOD ARGININE EQ 2MG BASE · TABLET · ORAL

Approval history

2025-08-12Labeling · Supplement 2 · standard — Letter ↗AP
2024-06-05Labeling · Supplement 1 · standard — Label ↗AP
2023-10-12Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →