Xdemvy

Treats Demodex blepharitis. NDA 217603, held by Tarsus. Lotilaner.

As of Nov 15, 2026, NDA 217603 (Xdemvy), held by Tarsus, was first approved by FDA on Jul 24, 2023, with 0 approved supplements and 0 published complete response letters.

First approved: Jul 24, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

XDEMVY is indicated for the treatment of Demodex blepharitis.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Jul 24, 2023	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xdemvy0.25% · solution/drops;ophthalmic	Lotilaner	RxReference drug

Identifiers

Application: NDA 217603
Drugs@FDA: Overview at FDA
Company: Tarsus Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters