Ethyol

Reduces cumulative renal toxicity associated with repeated administration of cisplatin. NDA 20221, held by Legacy. Amifostine.

As of Nov 14, 2026, NDA 20221 (Ethyol), held by Legacy, was first approved by FDA on Dec 8, 1995, with 22 approved supplements and 0 published complete response letters.

First approved: Dec 8, 1995
Review: Priority
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1, 5.1, 5.2 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below


Jun 24, 1999	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Review Label
Mar 15, 1996	Supplement 2Efficacy (new indication or use)	Approved	None posted
Dec 8, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Products

2 strengths and forms


Ethyol500MG/VIAL · injectable;injection	Amifostine	RxReference drug
Ethyol375MG/VIAL · injectable;injection	Amifostine	Discontinued

All 23 submissions, including labeling and manufacturing supplements


Jul 25, 2019	Supplement 36Labeling · Standard review	Approved	Label Letter
May 25, 2017	Supplement 33Labeling · Standard review	Approved	Label Letter
Dec 15, 2016	Supplement 32Labeling · Standard review	Approved	Label Letter
Mar 9, 2016	Supplement 30Manufacturing · Priority review	Approved	None posted
Jan 15, 2016	Supplement 31Manufacturing · Priority review	Approved	None posted
Aug 26, 2013	Supplement 28Manufacturing · Priority review	Approved	None posted
Nov 7, 2008	Supplement 24Labeling · Standard review	Approved	Letter Label
Mar 28, 2006	Supplement 20Labeling · Standard review	Approved	Letter
Mar 27, 2003	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 20, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Sep 10, 1999	Supplement 14Manufacturing · Priority review	Approved	None posted
Jun 24, 1999	Supplement 12Efficacy (new indication or use) · Priority review	Approved	Letter Review Label
Apr 1, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Mar 11, 1999	Supplement 10Labeling · Standard review	Approved	None posted
Feb 11, 1999	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 10, 1997	Supplement 9Manufacturing · Priority review	Approved	None posted
Feb 20, 1997	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 30, 1996	Supplement 3Manufacturing · Priority review	Approved	None posted
Dec 18, 1996	Supplement 5Manufacturing · Priority review	Approved	None posted
Nov 21, 1996	Supplement 4Manufacturing · Priority review	Approved	None posted
Mar 15, 1996	Supplement 2Efficacy (new indication or use)	Approved	None posted
Jan 23, 1996	Supplement 1Manufacturing · Priority review	Approved	None posted
Dec 8, 1995	Original applicationNew molecular entity · Priority review	Approved	Review

Identifiers

Application: NDA 20221
Drugs@FDA: Overview at FDA
Company: LEGACY

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