Is Ritlecitinib registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Ritlecitinib, including Litfulo (50 mg, Capsule, hard, SAR 3605.85).

Is Ritlecitinib approved by the US FDA?

Drugs@FDA lists 1 application product line for Ritlecitinib, including LITFULO (Prescription).

Are there safety signals or safety updates for Ritlecitinib?

US FDA: 1 entry (latest 2026-06-30).

Active substance

Ritlecitinib

SFDA 1
US FDA 1
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Litfulo	50 mg	Capsule, hard · Oral use	30 Blister	SAR 3605.85	NCE · Prescription	PFIZER INC	Valid

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
LITFULO	EQ 50MG BASE	capsule · oral	PFIZER	Prescription	23 Jun 2023

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
LITFULO	02543532	50 MG	CAPSULE · ORAL	PFIZER CANADA ULC

Safety signals and safety-related labeling changes

US FDA 30 Jun 2026 LITFULO — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ritlecitinib →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.