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.

CENTANY (NDA-050788)

(MUPIROCIN)

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

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07/10/2025 (SUPPL-9)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

Available data over decades of use with CENTANY ointment during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of mupirocin through intact human skin following topical administration of mupirocin was determined to be ? 1.25% of the administered dose based on urine monic acid excretion [see Clinical Pharmacology (12.3)]. No evidence of fetal harm was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses up to 22 and 11 times, respectively, the human topical dose based on body surface area.

The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data

Animal Data

Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced food consumption) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on body surface area.

Mupirocin administered subcutaneously to rats in a pre-and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

8.2 Lactation

PLLR conversion:

Risk Summary

There are no data on the presence of mupirocin in human or animal milk, the effects on the breast-fed infant or the effects on milk production. Systemic absorption of mupirocin through intact human skin following topical administration of mupirocin was determined to be ? 1.25% of the administered dose based on urine monic acid excretion [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CENTANY ointment and any potential adverse effects on the breast-fed infant from CENTANY ointment or from the underlying maternal condition.

Clinical Considerations

To minimize oral exposure of the drug to breastfeeding infants, a breast and/or nipple being treated with CENTANY ointment should be thoroughly washed prior to breastfeeding.

8.4 Pediatric Use

Additions and/or revisions underlined:

. . .

The safety and effectiveness of CENTANY ointment have not been established in pediatric patients younger than 2 months of age.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Important Administration Instructions

Advise the patient to administer CENTANY ointment as follows [see Dosage and Administration (2)] and Warnings and Precautions (5.2)]:

Use CENTANY ointment only as directed by your healthcare provider.
It is for topical use only.
Avoid contact with the eyes. If CENTANY ointment gets in or near the eyes, rinse thoroughly with water.
Stop CENTANY ointment and contact your healthcare provider if irritation, severe itching or rash occurs.

If impetigo has not improved in 3 to 5 days, contact your healthcare provider.

Lactation

Advise breastfeeding women to thoroughly wash the breast and/or nipple being treated with CENTANY ointment to prevent direct infant exposure [see Use in Specific Populations (8.2)].