Vfend

NDA 21630, held by Pf Prism Cv. Voriconazole.

As of Nov 14, 2026, NDA 21630 (Vfend), held by Pf Prism Cv, was first approved by FDA on Dec 19, 2003, with 38 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2003
Review: Standard
Supplements approved: 38
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Voriconazole 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 Voriconazole 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 39 submissions below


Jan 29, 2019	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Letter Label
Dec 21, 2004	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Dec 19, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vfend200MG/5ML · for suspension;oral	Voriconazole	RxReference drug

All 39 submissions, including labeling and manufacturing supplements


Feb 19, 2026	Supplement 50Labeling · Standard review	Approved	Label Letter
Jan 28, 2026	Supplement 49Labeling · Standard review	Approved	Label Letter
Mar 12, 2025	Supplement 47Labeling · Standard review	Approved	Label Letter
Aug 26, 2024	Supplement 46Manufacturing	Approved	Label Letter
Oct 18, 2022	Supplement 42Labeling · Standard review	Approved	Label Letter
Aug 16, 2022	Supplement 43Labeling · Standard review	Approved	Letter Label
Jan 28, 2022	Supplement 41Labeling · Standard review	Approved	Label Letter
Oct 13, 2021	Supplement 40Labeling · Standard review	Approved	Letter Label
Apr 15, 2021	Supplement 39Labeling · Standard review	Approved	Label Letter
Jan 25, 2021	Supplement 38Labeling · Standard review	Approved	Label Letter
Jan 14, 2021	Supplement 36Labeling · Standard review	Approved	Label Letter
Sep 4, 2020	Supplement 37Labeling · Standard review	Approved	Label Letter
Apr 30, 2019	Supplement 34Labeling · Standard review	Approved	Letter Label
Jan 29, 2019	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Letter Label
Oct 4, 2018	Supplement 33Labeling · Standard review	Approved	Letter
Jul 28, 2017	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 15, 2017	Supplement 31Labeling · Standard review	Approved	Label Letter
Feb 3, 2015	Supplement 28Labeling · Standard review	Approved	Letter Label
Apr 7, 2014	Supplement 27Labeling · Standard review	Approved	Letter Label
Nov 16, 2011	Supplement 26Labeling · Standard review	Approved	Letter Label
Jun 1, 2011	Supplement 24Labeling	Approved	Label Letter
Dec 15, 2010	Supplement 22Labeling	Approved	Label Letter
Nov 21, 2010	Supplement 23Labeling	Approved	Letter Label
Jun 17, 2010	Supplement 21Labeling	Approved	Label Letter
Jun 17, 2010	Supplement 20Labeling	Approved	Letter Label
Jun 17, 2010	Supplement 18Labeling · Standard review	Approved	Letter Label
Jun 17, 2010	Supplement 14Labeling · Standard review	Approved	Letter Label
May 30, 2008	Supplement 15Labeling · Standard review	Approved	Letter
Mar 10, 2008	Supplement 13Labeling · Standard review	Approved	Letter Label
Feb 5, 2008	Supplement 9Labeling · Standard review	Approved	Label Letter
Dec 1, 2006	Supplement 11Labeling · Standard review	Approved	Letter Label
May 19, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label
Mar 10, 2006	Supplement 8Labeling · Standard review	Approved	Letter Label
Dec 18, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
Jul 7, 2005	Supplement 5Labeling · Standard review	Approved	Letter Label
Mar 24, 2005	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 21, 2004	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Apr 21, 2004	Supplement 1Labeling · Standard review	Approved	Review Label Letter
Dec 19, 2003	Original applicationNew dosage form · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21630
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