Active substance
Difluprednate
- US FDA 9
- Health Canada 1
- US price lines 2
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DUREZOL | 0.05% | emulsion · ophthalmic | SANDOZ | Prescription | 23 Jun 2008 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | AMNEAL | Prescription | 17 Nov 2021 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | DR REDDYS | Prescription | 16 Nov 2022 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | EPIC PHARMA LLC | Prescription | 14 May 2024 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | CAPLIN | Prescription | 13 Dec 2024 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | UPSHER SMITH LABS | Prescription | 11 Feb 2025 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | MYLAN LABS LTD | Prescription | 20 Mar 2025 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | ALEMBIC | Prescription | 26 Jan 2026 |
| DIFLUPREDNATE | 0.05% | emulsion · ophthalmic | CIPLA | Discontinued | 9 Aug 2021 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| DUREZOL | 02415534 | 0.05 % / W/V | EMULSION · OPHTHALMIC | NOVARTIS PHARMACEUTICALS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DIFLUPREDNATE 0.05% EYE DROP | $9.68661 | per ML | 23 Sep 2026 |
| US NADAC | DUREZOL 0.05% EYE DROPS | $42.24913 | per ML | 23 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 15 Jul 2025 DUREZOL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations
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.