Quick answers
- What is Lifitegrast used for?
- The FDA-approved label (Xiidra, Novartis Pharmaceuticals Corporation, August 18, 2025) says: “Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lifitegrast have a boxed warning?
- No. None of the 3 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lifitegrast?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lifitegrast been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started May 10, 2022 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Lifitegrast?
- 3 companies list prescription products of Lifitegrast in the FDA NDC Directory, including Aurobindo Pharma Limited, Bausch & Lomb Incorporated and Novartis Pharmaceuticals Corporation.
What Lifitegrast is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).
— FDA label: Xiidra, Novartis Pharmaceuticals Corporation, effective August 18, 2025. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution/ drops · For solution |
|---|---|
| Route | Ophthalmic |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Xiidra |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| lifitegrast 50 mg/mL solution/ drops | Brand: Xiidra | $11.83 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Aurobindo Pharma Limited1 product
- Bausch & Lomb Incorporated1 product
- Novartis Pharmaceuticals Corporation1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA208073 XIIDRA | Bausch and Lomb Inc | July 11, 2016 | 3, latest April 4, 2024 2024: Manufacturing (CMC) · 2020: Labeling · 2017: Labeling |
Generic approvals (1)
- ANDA215063Eugia Pharma · November 7, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
May 10, 2022 · Class III · Terminated · D-0982-2022
Failed Impurities/Degradation Specifications.
Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Ma — Novartis Pharmaceuticals Corporation
-
May 10, 2022 · Class III · Terminated · D-0984-2022
Failed Impurities/Degradation Specifications.
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufa — Novartis Pharmaceuticals Corporation
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1801835, 1801840 |
|---|---|
| SPL set ID of the quoted label | 8589d376-ac10-4ddb-9c53-2e0c8d5675c4 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA208073, 1 ANDA |
| Active ingredients (FDA) | LIFITEGRAST |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xiidra, Novartis Pharmaceuticals Corporation, effective August 18, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →