Caspofungin Acetate

NDA 206110, held by Fresenius Kabi USA. Caspofungin Acetate.

As of Nov 14, 2026, NDA 206110 (Caspofungin Acetate), held by Fresenius Kabi USA, was first approved by FDA on Dec 30, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 30, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Caspofungin acetate for Injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age and older) for:

Empirical therapy for presumed fungal infections in febrile, neutropenic patients.
Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections.
Treatment of esophageal candidiasis.
Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 30, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Review Letter Label

Products

2 strengths and forms


Caspofungin Acetate50MG/VIAL · powder;intravenous	Caspofungin Acetate	Rx
Caspofungin Acetate70MG/VIAL · powder;intravenous	Caspofungin Acetate	Rx

All 3 submissions, including labeling and manufacturing supplements


Apr 1, 2021	Supplement 3Labeling · Standard review	Approved	Letter Label
Jun 28, 2018	Supplement 1Labeling · Standard review	Approved	Letter Label
Dec 30, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Review Letter Label

Identifiers

Application: NDA 206110
Drugs@FDA: Overview at FDA
Company: Fresenius Kabi USA

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