Drug Safety-related Labeling Changes (SrLC)

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Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

REZZAYO (NDA-217417)

(REZAFUNGIN ACETATE)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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07/16/2026 (SUPPL-7)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The safety and effectiveness of REZZAYO have been established in pediatric patients 12 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Use of REZZAYO in this age group, for this indication, is supported by evidence from adequate and well-controlled studies of REZZAYO in adults [weight range: 34 to 154.5 kg], along with additional population pharmacokinetic analyses demonstrating that age or body weight had no clinically meaningful effect on rezafungin exposures. There have been no clinical studies conducted with REZZAYO in pediatric patients [see Dosage and Administration (2.1), Clinical Pharmacology (12.3), and Clinical Studies (14)].

The safety and effectiveness of REZZAYO have not been established in pediatric patients younger than 12 years old.

12/10/2025 (SUPPL-8)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Hypersensitivity Reactions, including Anaphylaxis

Newly added subsection:

Cases of serious hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving REZZAYO. If these reactions occur, discontinue REZZAYO and administer appropriate treatment [see Adverse Reactions (6.2)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions (5.1)]

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during post approval use of REZZAYO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune system disorders: drug hypersensitivity, anaphylactic reaction

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Serious Allergic Reactions

Advise patients that serious allergic reactions could occur with REZZAYO and that serious reactions require immediate treatment. [see Warnings and Precautions (5.1)]

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