Prescription medicine

Rezafungin Brand names: Rezzayo

Rezafungin (Rezzayo) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the rezafungin FDA label on DailyMed (effective July 1, 2026, Melinta Therapeutics, LLC); the NDA 217417 record on Drugs@FDA; every rezafungin label on DailyMed.

Highlights of the record

FDA label of July 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
REZZAYO is an echinocandin antifungal indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis.

Forms and strengths

200 mg

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: March 22, 2023 Rezzayo, Mundipharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: July 14, 2038 Rezzayo injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 87 through July 30, 2026

What is rezafungin used for?

From the label: indications and usage
REZZAYO is an echinocandin antifungal indicated in adults and pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data for REZZAYO. ( 1 , 12.4 , 14 ) Limitations of Use REZZAYO has not been studied in patients with endocarditis, osteomyelitis, and meningitis due to Candida. […]

FDA pharmacologic class: Echinocandin Antifungal.

Source: FDA drug label (REZZAYO), NDA217417 (Mundipharma), as published by Melinta Therapeutics, LLC, effective July 1, 2026 (SPL set 90073508-6dca-4d27-aa5a-ed837737c35b), via openFDA; the full label on DailyMed

Is there a generic for rezafungin (Rezzayo)?

No generic rezafungin is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 7 patents for Rezzayo injection: the compound patent runs to July 14, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2023 earliest approval on file
2038 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do FAERS reports show for rezafungin?

The FDA Adverse Event Reporting System holds 87 reports that list rezafungin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 16 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Off Label Use (a use or a product term, not a reaction)37
Product Prescribing Issue (a use or a product term, not a reaction)12
No Adverse Event (a use or a product term, not a reaction)11
Drug Ineffective (a use or a product term, not a reaction)6
Product Dose Omission Issue (a use or a product term, not a reaction)4
Product Use Issue (a use or a product term, not a reaction)4
Candida Infection3
Condition Aggravated (a use or a product term, not a reaction)3

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other echinocandin antifungals: the pharmacologic class, with prices and generics
Rezafungin side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other