Eraxis

NDA 21632, held by Vicuron Holdings. Anidulafungin.

As of Nov 14, 2026, NDA 21632 (Eraxis), held by Vicuron Holdings, was first approved by FDA on Feb 17, 2006, with 15 approved supplements and 0 published complete response letters.

First approved: Feb 17, 2006
Review: Standard
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ERAXIS is an echinocandin antifungal indicated for the treatment of the following infections:

Candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric patients (1 month of age and older)
Esophageal candidiasis in adults Limitations of use
ERAXIS has not been studied in adult and pediatric patients with endocarditis, osteomyelitis, and meningitis due to Candida or in sufficient numbers of neutropenic patients. The dosage of ERAXIS for the treatment of Candida dissemination into the CNS and the eye has not been established. ( 1.3, 5.3, 8.4 )
ERAXIS is associated with high relapse rates in esophageal candidiasis. ( 1.3, 14.2 ) 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Sep 22, 2020	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 17, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Eraxis50MG/VIAL · powder;intravenous	Anidulafungin	RxReference drug
Eraxis100MG/VIAL · powder;intravenous	Anidulafungin	RxReference drug

All 16 submissions, including labeling and manufacturing supplements


Oct 5, 2020	Supplement 30Labeling · Standard review	Approved	Letter Label
Sep 22, 2020	Supplement 29Labeling · Standard review	Approved	Label Letter
Sep 22, 2020	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 5, 2018	Supplement 26Labeling · Standard review	Approved	Letter Label
Aug 17, 2017	Supplement 24Labeling · Standard review	Approved	Letter Label
Dec 2, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Jun 9, 2014	Supplement 20Manufacturing · Standard review	Approved	None posted
Mar 28, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 20, 2012	Supplement 11Labeling · Standard review	Approved	Letter Label
Nov 4, 2010	Supplement 13Labeling	Approved	Letter
Jun 5, 2009	Supplement 10Manufacturing · Standard review	Approved	Letter Label
Nov 9, 2007	Supplement 6Labeling · Standard review	Approved	Letter Label
Feb 2, 2007	Supplement 4Labeling · Standard review	Approved	Label Letter
Nov 15, 2006	Supplement 3Manufacturing	Approved	Letter Label
Aug 7, 2006	Supplement 2Manufacturing	Approved	Letter Label
Feb 17, 2006	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21632
Drugs@FDA: Overview at FDA
Company: Vicuron Holdings

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