Xiidra Novartis Europharm Limited · Application withdrawn · ATC S01XA25
Therapeutic indication (EMA)
Treatment of moderate to severe dry eye disease in adults for whom prior artificial tears has not been sufficient
Active substance
Lifitegrast
- SFDA 2
- US FDA 4
- EMA 1
- Health Canada 1
- US price lines 1
- Safety 1
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| XIIDRA 50 MG/ML EYE DROPS | 50 mg/ml | Eye drops, solution · Ophthalmic use | 60 Single Dose Container | SAR 361.50 | NCE · Prescription | Bausch & Lomb, Incorporated | Valid |
| XIIDRA 50 MG/ML EYE DROPS | 50 mg/ml | Eye drops, solution · Ophthalmic use | 60 | SAR 361.50 | NCE · Prescription | Shire US, Inc. | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
SJOGREN'S SYNDROME
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| XIIDRA | 5% | solution/drops · ophthalmic | BAUSCH AND LOMB INC | Prescription | 11 Jul 2016 |
| LIFITEGRAST | 5% | solution/drops · ophthalmic | MICRO LABS | Discontinued | 4 Aug 2023 |
| LIFITEGRAST | 5% | solution/drops · ophthalmic | EUGIA PHARMA | Discontinued | 7 Nov 2023 |
| LIFITEGRAST | 5% | solution/drops · ophthalmic | INGENUS PHARMS LLC | Discontinued | 3 Oct 2024 |
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| XIIDRA | 02471027 | 5 % / W/V | SOLUTION · OPHTHALMIC | BAUSCH & LOMB INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | XIIDRA 5% EYE DROPS | $11.832 | per EA | 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 4 Jun 2020 XIIDRA — safety-related labeling change
Labeling sections changed: Adverse Reactions; 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.