Regulatory PathRegulatory requirements compared

Active substance

Viloxazine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
VIVALAN TAB 50MG50 mgTablet · Oral use100 Tablet ContainerSAR 17.70NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed
VIVALAN TAB 50MG50 mgTablet · Oral use30 BlisterSAR 41.15NCE · PrescriptionAstraZenecaWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
QELBREEEQ 100MG BASE; EQ 150MG BASE; EQ 200MG BASEcapsule, extended release · oralSUPERNUS PHARMSPrescription2 Apr 2021

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACQELBREE ER 100 MG CAPSULE$12.73257per EA23 Sep 2026
US NADACQELBREE ER 150 MG CAPSULE$12.731per EA23 Sep 2026
US NADACQELBREE ER 200 MG CAPSULE$12.73799per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

  • US FDA 23 Jan 2025 QELBREE — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for viloxazine →

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.