Xalatan

Reduces elevated intraocular pressure (IOP). NDA 20597, held by Upjohn. Latanoprost.

As of Nov 13, 2026, NDA 20597 (Xalatan), held by Upjohn, was first approved by FDA on Jun 5, 1996, with 34 approved supplements and 0 published complete response letters.

First approved: Jun 5, 1996
Review: Priority
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Dec 20, 2002	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jun 5, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Xalatan0.005% · solution/drops;ophthalmic	Latanoprost	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Dec 19, 2022	Supplement 54Labeling · Standard review	Approved	Label
Sep 1, 2020	Supplement 52Labeling · Standard review	Approved	Label Letter
Apr 10, 2017	Supplement 51Labeling · Standard review	Approved	Letter Label
Nov 25, 2014	Supplement 48Labeling · Standard review	Approved	Label Letter
Nov 25, 2014	Supplement 45Labeling · Standard review	Approved	Label Letter
Apr 3, 2014	Supplement 49Manufacturing · Priority review	Approved	None posted
Mar 13, 2013	Supplement 46Manufacturing · Priority review	Approved	Label
Mar 13, 2012	Supplement 44Labeling · Standard review	Approved	Label Letter
Aug 31, 2010	Supplement 36Labeling · Standard review	Approved	Letter Label
Aug 31, 2010	Supplement 35Labeling · Standard review	Approved	Letter Label
Jul 29, 2010	Supplement 39Manufacturing	Approved	None posted
Jul 14, 2003	Supplement 29Manufacturing · Priority review	Approved	Letter
Jul 14, 2003	Supplement 28Labeling · Standard review	Approved	Letter
Dec 20, 2002	Supplement 10Efficacy (new indication or use) · Priority review	Approved	Label Letter
Nov 15, 2002	Supplement 26Manufacturing · Priority review	Approved	Review
Aug 26, 2002	Supplement 25Manufacturing · Priority review	Approved	Label Letter
Jun 21, 2002	Supplement 24Manufacturing · Priority review	Approved	None posted
Nov 26, 2001	Supplement 23Manufacturing · Priority review	Approved	Label
Aug 8, 2001	Supplement 19Labeling · Standard review	Approved	Label
May 14, 2001	Supplement 22Manufacturing · Priority review	Approved	None posted
Apr 23, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Dec 26, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Dec 11, 2000	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 9, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 25, 2000	Supplement 18Labeling · Standard review	Approved	None posted
Jun 2, 2000	Supplement 13Manufacturing · Priority review	Approved	Review
Jan 24, 2000	Supplement 11Manufacturing · Priority review	Approved	Review
Oct 8, 1999	Supplement 12Labeling · Standard review	Approved	None posted
Jul 16, 1999	Supplement 8Labeling · Standard review	Approved	None posted
Mar 22, 1999	Supplement 7Labeling · Standard review	Approved	None posted
Dec 9, 1998	Supplement 2Manufacturing · Priority review	Approved	None posted
Nov 1, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Jul 31, 1998	Supplement 5Manufacturing · Priority review	Approved	Review
Jun 23, 1998	Supplement 1Labeling · Standard review	Approved	None posted
Jun 5, 1996	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20597
Drugs@FDA: Overview at FDA
Company: Upjohn

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