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FDA NDA · NDA218276

FABHALTA

iptacopan

Sponsor: NOVARTIS

APPLICATION
NDA218276
TYPE
NDA
ORIGINAL APPROVAL
2023-12-05
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

FABHALTA · ReferencePrescription
IPTACOPAN HYDROCHLORIDE EQ 200MG BASE · CAPSULE · ORAL

Approval history

2026-07-16Efficacy · Supplement 7 · priority — Letter ↗AP
2025-03-20Efficacy · Supplement 4 · priority — Label ↗AP
2024-08-07Efficacy · Supplement 1 · priority — Label ↗AP
2024-05-24REMS · Supplement 3 — Letter ↗AP
2024-03-26Labeling · Supplement 2 · standard — Label ↗AP
2023-12-05Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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