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.

SUSTOL (NDA-022445)

(GRANISETRON)

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

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02/23/2026 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Serious Injection Site Reactions

Section title revised

Extensive changes; please refer to label for complete information

6 Adverse Reactions

Additions and/or revisions underlined:

Serious Injection Site Reactions [see Warnings and Precautions (5.10]

6.1 Clinical Trials Experience

Extensive changes; please refer to label for complete information

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Injection Site Reactions [see Warnings and Precautions (5.1)]

Inform the patient that ISRs may occur and may include infections, prolonged bleeding, bruising, hematomas, nodules, and pain, and tenderness.

…

MEDICATION GUIDE

Additions and/or revisions underlined

What is the most important information I should know about SUSTOL? SUSTOL can cause serious side effects, including:

Serious Injection site reactions. Some injection site reactions may be serious or severe and require medical care. Injection site reactions may include infections, prolonged bleeding, bruising, swelling that is caused by blood that collects under the skin (hematoma), small bumps (nodules) at the injection site, pain, and tenderness. Some injection site reactions can happen up to 2 weeks or more after receiving SUSTOL.

…

05/25/2023 (SUPPL-10)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.2 Lactation

Risk Summary

(Additions and/or revisions underlined)

There are no data on the presence of SUSTOL in human milk, the effects of SUSTOL on the breastfed infant, or the effects of SUSTOL on milk production. The lack of clinical data during lactation precludes a clear determination of the risk of SUSTOL to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUSTOL and any potential adverse effects on the breastfed infant from SUSTOL or from the underlying maternal condition.

8.4 Pediatric Use

(Additions and/or revisions underlined)

The safety and effectiveness of SUSTOL in pediatric patients under 18 years of age have not been established.

SUSTOL is not recommended for use in pediatric patients less than 12 years of age because the product administration requires a large gauge needle and an extended administration time.