Foscavir

Treats CMV retinitis. NDA 20068, held by Clinigen Hlthcare. Foscarnet Sodium.

As of Nov 13, 2026, NDA 20068 (Foscavir), held by Clinigen Hlthcare, was first approved by FDA on Sep 27, 1991, with 20 approved supplements and 0 published complete response letters.

First approved: Sep 27, 1991
Review: Priority
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS CMV Retinitis FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS); CONGENITAL OR NEONATAL CMV DISEASE; OR NONIMMUNOCOMPROMISED INDIVIDUALS. Mucocutaneous Acyclovir Resistant HSV Infections FOSCAVIR is indicated for the treatment of acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jan 24, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 24, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Jun 16, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Sep 27, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Foscavir6GM/250ML (24MG/ML) · solution;intravenous	Foscarnet Sodium	RxReference drug
Foscavir12GM/500ML (24MG/ML) · solution;intravenous	Foscarnet Sodium	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 28, 2020	Supplement 25Manufacturing	Approved	Label Letter
Feb 24, 2017	Supplement 23Labeling · Standard review	Approved	Letter Label
Nov 10, 2016	Supplement 22Labeling · Standard review	Approved	Letter Label
May 29, 2015	Supplement 21Manufacturing	Approved	None posted
Nov 7, 2014	Supplement 20Labeling · Standard review	Approved	Label Letter
Jun 10, 2014	Supplement 19Manufacturing	Approved	None posted
Feb 10, 2012	Supplement 18Manufacturing	Approved	Label
Nov 27, 2007	Supplement 17Labeling · Standard review	Approved	Label
May 15, 2006	Supplement 16Labeling · Standard review	Approved	Letter Label
Jun 13, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Jun 13, 2000	Supplement 13Labeling · Standard review	Approved	None posted
Nov 16, 1998	Supplement 12Manufacturing	Approved	None posted
Mar 31, 1997	Supplement 9Labeling · Standard review	Approved	None posted
Jan 24, 1997	Supplement 8Labeling · Standard review	Approved	None posted
Jan 24, 1997	Supplement 7Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 24, 1997	Supplement 6Efficacy (new indication or use) · Standard review	Approved	None posted
Jan 3, 1997	Supplement 10Manufacturing	Approved	None posted
Dec 12, 1995	Supplement 2Labeling	Approved	None posted
Nov 17, 1995	Supplement 5Labeling · Standard review	Approved	None posted
Jun 16, 1995	Supplement 3Efficacy (new indication or use)	Approved	None posted
Sep 27, 1991	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20068
Drugs@FDA: Overview at FDA
Company: Clinigen Healthcare

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