Regulatory PathRegulatory requirements compared

Active substance

Eflornithine

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
IWILFINEQ 192MG BASEtablet · oralUSWMPrescription13 Dec 2023
ORNIDYL200MG/MLinjectable · injectionSANOFI AVENTIS USDiscontinued28 Nov 1990
VANIQA13.9%cream · topicalABBVIEDiscontinued27 Jul 2000

EMA European Union — centrally authorised medicines

Vaniqa Almirall, S.A. · Authorised · authorised 19 Mar 2001 · ATC D11AX

Therapeutic indication (EMA)

Treatment of facial hirsutism in women.

Ifinwil Norgine B.V. · Application withdrawn · ATC L01XX79

Therapeutic indication (EMA)

Treatment of high-risk neuroblastoma responsive to prior multiagent, multimodality therapy

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
VANIQA0224383713.9 % / W/WCREAM · TOPICALCIPHER PHARMACEUTICALS INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffEflornithine 11.5% cream£56.8760 gram1 Oct 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.5.5.1.2. Medicines for the treatment of 2nd stage African trypanosomiasis · core
    Gambiense trypanosomiasis
    Parenteral > General injections > IV: 200 mg per mL in 50 mL bottle (hydrochloride)

Safety signals and safety-related labeling changes

All safety entries for eflornithine →

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.