Active substance
Azelaic acid
- SFDA 5
- US FDA 8
- Health Canada 1
- US price lines 2
- NHS prices 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Azebat | 20 % (W/W) | Cream · Topical | 1 Tube | SAR 24.50 | Generic · Prescription | BATTERJEE PHARMACETICAL FACTORY | Valid |
| SKINOREN 20% CREAM | 20 % | Cream · Topical | 1 Tube | SAR 32.70 | NCE · Prescription | LEO Pharma A/S Denmark | Valid |
| AZCLEAR ACTION MEDICATED LOTION | 20 % | Lotion · Topical | 1 Tube | SAR 19.10 | NCE · Prescription | EGO PHARMACEUTICALS | Withdrawn by MAH · Not Marketed |
| SKINOREN 20% CREAM | 20 % | Cream · Topical | 1 Tube | SAR 32.70 | NCE · Prescription | BAYER PHARMA AG | Withdrawn by MAH · Not Marketed |
| SKINOREN 20% CREAM | 20 % | Cream · Topical | 1 Tube | SAR 32.70 | NCE · Prescription | INTENDIS MANUFACTURING S.P.A. | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ERYTHEMA; PAPULOPUSTULAR ROSACEA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AZELEX | 20% | cream · topical | ALMIRALL | Prescription | 13 Sep 1995 |
| FINACEA | 15% | gel · topical | LEO PHARMA AS | Prescription | 24 Dec 2002 |
| FINACEA | 15% | aerosol, foam · topical | LEO PHARMA AS | Prescription | 29 Jul 2015 |
| AZELAIC ACID | 15% | gel · topical | GLENMARK SPECLT | Prescription | 19 Nov 2018 |
| AZELAIC ACID | 15% | gel · topical | ACTAVIS LABS UT INC | Prescription | 19 Nov 2018 |
| AZELAIC ACID | 15% | gel · topical | ENCUBE | Prescription | 19 Nov 2018 |
| AZELAIC ACID | 15% | gel · topical | SUN PHARMA CANADA | Prescription | 23 Aug 2019 |
| AZELAIC ACID | 15% | aerosol, foam · topical | AUROBINDO PHARMA USA | Discontinued | 7 Oct 2020 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FINACEA | 02270811 | 15 % / W/W | GEL · TOPICAL | LEO PHARMA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AZELAIC ACID 15% GEL | $0.44069 | per GM | 23 Sep 2026 |
| US NADAC | FINACEA 15% FOAM | $8.33372 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Azelaic acid 15% gel | £7.48 | 30 gram | 1 Oct 2026 |
| NHS Drug Tariff | Azelaic acid 20% cream | £7.48 | 50 gram | 1 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.
Safety signals and safety-related labeling changes
- US FDA 1 Nov 2021 FINACEA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Dec 2020 FINACEA — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.