Medicine
Xdemvy 2.5 mg/mL eye drops
Xdemvy 2.5 mg/mL eye drops is a prescription medicine containing Lotilaner for ophthalmic use, marketed by Tarsus Pharmaceuticals, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store at 15°C to 25°C (59°F to 77°F).
Key facts
- Active ingredient (INN)
- Lotilaner
- Brand
- Xdemvy
- Strength
- 2.5 mg/mL
- Dosage form
- Eye drops
- Route
- Ophthalmic
- Packs
- 1 bottle
- Marketing authorisation holder
- Tarsus Pharmaceuticals
- Manufacturer
- Tarsus Pharmaceuticals
- Origin register
- US FDA, United States
- Storage
- Store at 15°C to 25°C (59°F to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 14 August 2023
- Identifiers
- RxCUI 2644507, 2644512DailyMed set ID ccd9e37c-654e-4e84-8c85-6523457df979NDC 81942-125Application NDA217603
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle, dropper in 1 carton / 10 mL in 1 bottle, dropper | 81942-125-01 | Tarsus Pharmaceuticals | 14 August 2023 |
| 1 bottle, dropper in 1 carton / 1.5 mL in 1 bottle, dropper | 81942-125-99 | Tarsus Pharmaceuticals | 14 August 2023 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 24 July 2023 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Lotilaner is an ectoparasiticide indicated for the treatment of Demodex blepharitis. It is available as eye drops for ophthalmic use. MedsAcross supplies Lotilaner for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about LotilanerFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- XDEMVY prescribing information (Tarsus Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Xdemvy 2.5 mg/mL eye drops for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.