Natacyn

Treats fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms…. NDA 50514, held by Harrow Eye. Natamycin.

As of Nov 13, 2026, NDA 50514 (Natacyn), held by Harrow Eye, was first approved by FDA on Oct 30, 1978, with 9 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1978
Review: Priority
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE: NATACYN (natamycin ophthalmic suspension) 5% is indicated for the treatment of fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms including Fusarium solani keratitis. As in other forms of suppurative keratitis, initial and sustained therapy of fungal keratitis should be determined by the clinical diagnosis, laboratory diagnosis by smear and culture of corneal scrapings and drug response. Whenever possible the in vitro activity of natamycin against the responsible fungus should be determined. The effectiveness of natamycin as a single agent in fungal endophthalmitis has not been established.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Oct 30, 1978	Original applicationNew dosage form · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Natacyn5% · suspension;ophthalmic	Natamycin	RxReference drug

All 10 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Nov 17, 2025	Supplement 22Labeling · Standard review	Approved	Label Letter
Jul 18, 2008	Supplement 9Labeling · Standard review	Approved	Review Letter Label
Dec 4, 2002	Supplement 10Manufacturing · Priority review	Approved	None posted
Oct 19, 2000	Supplement 8Manufacturing · Priority review	Approved	None posted
May 2, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Nov 1, 1995	Supplement 6Manufacturing · Priority review	Approved	None posted
Jun 30, 1992	Supplement 4Labeling	Approved	None posted
Feb 10, 1992	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 8, 1991	Supplement 3Manufacturing · Priority review	Approved	None posted
Oct 30, 1978	Original applicationNew dosage form · Priority review	Approved	None posted

Identifiers

Application: NDA 50514
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