Quick answers
- What is Lotilaner ophthalmic solution used for?
- The FDA-approved label (Xdemvy, Tarsus Pharmaceuticals, Inc., August 10, 2024) says: “XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Lotilaner ophthalmic solution have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Lotilaner ophthalmic solution?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Lotilaner ophthalmic solution been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Lotilaner ophthalmic solution?
- 1 company lists prescription products of Lotilaner ophthalmic solution in the FDA NDC Directory, including Tarsus Pharmaceuticals, Inc..
What Lotilaner ophthalmic solution is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XDEMVY is indicated for the treatment of Demodex blepharitis. XDEMVY is an ectoparasiticide (anti-parasitic) indicated for the treatment of Demodex blepharitis.
— FDA label: Xdemvy, Tarsus Pharmaceuticals, Inc., effective August 10, 2024. Read the full label on DailyMed →
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.
Forms and how it is given
| Dosage forms | Solution/ drops |
|---|---|
| Route | Ophthalmic |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Xdemvy |
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.
- Tarsus Pharmaceuticals, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217603 XDEMVY | Tarsus | July 24, 2023 | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2644507, 2644512 |
|---|---|
| SPL set ID of the quoted label | ccd9e37c-654e-4e84-8c85-6523457df979 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA217603 |
| Active ingredients (FDA) | LOTILANER |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xdemvy, Tarsus Pharmaceuticals, Inc., effective August 10, 2024; 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 →