Vfend

NDA 21266, held by Pf Prism Cv. Voriconazole.

As of Nov 14, 2026, NDA 21266 (Vfend), held by Pf Prism Cv, was first approved by FDA on May 24, 2002, with 42 approved supplements and 0 published complete response letters.

First approved: May 24, 2002
Review: Standard
Supplements approved: 42
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VFEND is an azole antifungal indicated for the treatment of adults and pediatric patients 2 years of age and older with:

Invasive aspergillosis
Candidemia in non-neutropenics and other deep tissue Candida infections
Esophageal candidiasis
Serious fungal infections caused by Scedosporium apiospermum and Fusarium species including Fusarium solani, in patients intolerant of, or refractory to, other therapy 1.1 Invasive Aspergillosis VFEND is indicated in adults and pediatric patients (2 years of age and older) for the treatment of invasive aspergillosis (IA). In clinical trials, the majority of isolates recovered were Aspergillus fumigatus.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 43 submissions below


Jan 29, 2019	Supplement 39Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 21, 2004	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
May 24, 2002	Original applicationNew molecular entity · Standard review	Approved	Label Review Letter

Products

2 strengths and forms


Vfend50MG · tablet;oral	Voriconazole	RxReference drug
Vfend200MG · tablet;oral	Voriconazole	RxReference drug

All 43 submissions, including labeling and manufacturing supplements


Feb 19, 2026	Supplement 60Labeling · Standard review	Approved	Label Letter
Jan 28, 2026	Supplement 59Labeling · Standard review	Approved	Label Letter
Mar 12, 2025	Supplement 57Labeling · Standard review	Approved	Label Letter
Oct 18, 2022	Supplement 53Labeling · Standard review	Approved	Label Letter
Aug 16, 2022	Supplement 54Labeling · Standard review	Approved	Letter Label
Jan 28, 2022	Supplement 52Labeling · Standard review	Approved	Label Letter
Oct 13, 2021	Supplement 51Labeling · Standard review	Approved	Letter Label
Apr 15, 2021	Supplement 50Labeling · Standard review	Approved	Label Letter
Jan 25, 2021	Supplement 49Labeling · Standard review	Approved	Label Letter
Jan 14, 2021	Supplement 47Labeling · Standard review	Approved	Label Letter
Sep 4, 2020	Supplement 48Labeling · Standard review	Approved	Label Letter
Apr 30, 2019	Supplement 45Labeling · Standard review	Approved	Letter Label
Jan 29, 2019	Supplement 39Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 28, 2017	Supplement 43Labeling · Standard review	Approved	Letter Label
Jun 15, 2017	Supplement 41Labeling · Standard review	Approved	Label Letter
Feb 3, 2015	Supplement 38Labeling · Standard review	Approved	Letter Label
Apr 7, 2014	Supplement 37Labeling · Standard review	Approved	Label Letter
Mar 1, 2013	Supplement 36Manufacturing · Standard review	Approved	None posted
Nov 16, 2011	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 1, 2011	Supplement 33Labeling	Approved	Label Letter
Dec 15, 2010	Supplement 34Labeling · Standard review	Approved	None posted
Dec 15, 2010	Supplement 31Labeling	Approved	Label Letter
Dec 15, 2010	Supplement 22Labeling · Standard review	Approved	None posted
Nov 21, 2010	Supplement 32Labeling	Approved	Letter Label
Jun 17, 2010	Supplement 30Labeling	Approved	Label Letter
Jun 17, 2010	Supplement 29Labeling	Approved	Letter Label
Jun 17, 2010	Supplement 27Labeling · Standard review	Approved	Letter Label
Jun 17, 2010	Supplement 25Labeling · Standard review	Approved	Letter Label
May 30, 2008	Supplement 26Labeling · Standard review	Approved	Letter
Mar 10, 2008	Supplement 23Labeling · Standard review	Approved	Letter Label
Feb 5, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 1, 2006	Supplement 19Labeling · Standard review	Approved	Letter Label
May 19, 2006	Supplement 18Labeling · Standard review	Approved	Letter Label
Mar 10, 2006	Supplement 15Labeling · Standard review	Approved	Label Letter
Dec 18, 2005	Supplement 13Labeling · Standard review	Approved	Letter Label
Jul 7, 2005	Supplement 12Labeling · Standard review	Approved	Letter Label
Mar 24, 2005	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 21, 2004	Supplement 9Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 21, 2004	Supplement 6Labeling · Standard review	Approved	Review Label Letter
Apr 21, 2004	Supplement 5Labeling · Standard review	Approved	Review Label Letter
Feb 4, 2004	Supplement 7Labeling · Standard review	Approved	Label Letter
Mar 28, 2003	Supplement 2Labeling · Standard review	Approved	Letter Label
May 24, 2002	Original applicationNew molecular entity · Standard review	Approved	Label Review Letter

Identifiers

Application: NDA 21266
Drugs@FDA: Overview at FDA
Company: PF PRISM CV

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