Vexol

NDA 20474, held by Harrow Eye. Rimexolone.

As of Nov 14, 2026, NDA 20474 (Vexol), held by Harrow Eye, was first approved by FDA on Dec 30, 1994, with 18 approved supplements and 0 published complete response letters.

First approved: Dec 30, 1994
Review: Priority
Supplements approved: 18
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Dec 30, 1994	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vexol1% · suspension/drops;ophthalmic	Rimexolone	Discontinued

All 19 submissions, including labeling and manufacturing supplements


Feb 22, 2012	Supplement 21Labeling · Standard review	Approved	Letter Label
Oct 18, 2007	Supplement 19Labeling · Standard review	Approved	Letter Label
Apr 17, 2003	Supplement 16Labeling · Standard review	Approved	Letter Label
Mar 16, 2001	Supplement 15Manufacturing · Priority review	Approved	None posted
Sep 18, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Feb 18, 2000	Supplement 13Manufacturing · Priority review	Approved	None posted
Nov 9, 1999	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 17, 1999	Supplement 12Manufacturing · Priority review	Approved	None posted
Apr 7, 1999	Supplement 11Manufacturing · Priority review	Approved	None posted
Mar 26, 1999	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 11, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 5, 1999	Supplement 10Manufacturing · Priority review	Approved	None posted
Jan 22, 1999	Supplement 8Manufacturing · Priority review	Approved	None posted
Sep 11, 1998	Supplement 7Labeling · Standard review	Approved	None posted
May 1, 1998	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 20, 1998	Supplement 3Manufacturing · Priority review	Approved	None posted
Aug 14, 1996	Supplement 2Labeling · Standard review	Approved	None posted
May 10, 1995	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 30, 1994	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20474
Drugs@FDA: Overview at FDA
Company: Harrow Eye LLC

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