Active substance
Acitretin
- SFDA 4
- US FDA 8
- Health Canada 6
- US price lines 3
- NHS prices 2
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| NEOTIGASON 10MG CAPS | 10 mg | Capsule, hard · Oral use | 30 Blister | SAR 97.60 | NCE · Prescription | ACTAVIS | Valid |
| NEOTIGASON 25MG CAPS | 25 mg | Capsule, hard · Oral use | 30 Blister | SAR 195.20 | NCE · Prescription | ACTAVIS | Valid |
| NEOTIGASON 10MG CAPS | 10 mg | Capsule, hard · Oral use | 30 Blister | SAR 95.65 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
| NEOTIGASON 25MG CAPS | 25 mg | Capsule, hard · Oral use | 30 Blister | SAR 181.10 | NCE · Prescription | ROCHE | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
LICHEN PLANUS; PSORIASIS; SYSTEMIC LUPUS ERYTHEMATOSUS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ACITRETIN | 10MG; 25MG | capsule · oral | BARR LABS INC | Prescription | 4 Apr 2013 |
| ACITRETIN | 17.5MG; 22.5MG | capsule · oral | TEVA PHARMS USA | Prescription | 4 Apr 2013 |
| ACITRETIN | 10MG; 17.5MG; 22.5MG; 25MG | capsule · oral | SIGMAPHARM LABS LLC | Prescription | 22 May 2015 |
| ACITRETIN | 10MG; 25MG | capsule · oral | MYLAN | Prescription | 10 Sep 2015 |
| ACITRETIN | 10MG; 17.5MG; 22.5MG; 25MG | capsule · oral | IMPAX LABS INC | Prescription | 23 Dec 2015 |
| ACITRETIN | 10MG; 17.5MG; 25MG | capsule · oral | ALEMBIC | Prescription | 5 Aug 2024 |
| SORIATANE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 17.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | capsule · oral | STIEFEL LABS INC | Discontinued | 28 Oct 1996 |
| ACITRETIN | 17.5MG; 22.5MG | capsule · oral | MYLAN | Discontinued | 10 Sep 2015 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| MINT-ACITRETIN | 02468840 | 10 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| MINT-ACITRETIN | 02468859 | 25 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| SORIATANE | 02070847 | 10 MG | CAPSULE · ORAL | ALLERGAN INC |
| SORIATANE | 02070863 | 25 MG | CAPSULE · ORAL | ALLERGAN INC |
| TARO-ACITRETIN | 02466074 | 10 MG | CAPSULE · ORAL | TARO PHARMACEUTICALS INC |
| TARO-ACITRETIN | 02466082 | 25 MG | CAPSULE · ORAL | TARO PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | ACITRETIN 10 MG CAPSULE | $2.59463 | per EA | 23 Sep 2026 |
| US NADAC | ACITRETIN 17.5 MG CAPSULE | $4.51838 | per EA | 23 Sep 2026 |
| US NADAC | ACITRETIN 25 MG CAPSULE | $3.5423 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Acitretin 10mg capsules | £16.07 | 60 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Acitretin 25mg capsules | £55.24 | 60 capsule | 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
- EMA PRAC 3 Sep 2026 PRAC signal: Erectile dysfunction
Action for MAH: update of the product information: No - US FDA 27 Sep 2017 SORIATANE — safety-related labeling change
Labeling sections changed: 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.