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.

ALTABAX (NDA-022055)

(RETAPAMULIN)

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

Download Data

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09/10/2019 (SUPPL-7)

Approved Drug Label (PDF)

6 Adverse Reactions

Clinical Studies Experience

In this section, all instances of ‘studies’ are replaced by ‘trials’.

All instances of ‘patients’ are replaced by ‘subjects’.

8 Use in Specific Populations

Pregnancy

Risk Summary

There are no available data on ALTABAX use in pregnant women to inform any drug associated risk for major birth defects, miscarriage or adverse maternal or fetal outcomes. Retapamulin is negligibly absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to the retapamulin.

Animal reproduction studies were not conducted with ALTABAX. However, in animal studies where retapamulin was administered by oral gavage or intravenous infusion to pregnant rats and rabbits, respectively, during organogenesis, maternal toxicity was seen at doses greater than or equal to 150 mg/kg/day and 7.2 mg/kg/day (8-fold the maximum achievable human exposure based on AUC) for oral and intravenous routes, respectively. The estimated 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 background risk of major birth defects in clinically recognized pregnancies is 2% to 4% and of miscarriage is 15% to 20%, respectively.

Lactation

Risk Summary

There are no data available on the presence of retapamulin in human milk, its effects on the breastfed infant or its effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the negligible systemic absorption of retapamulin in humans following topical administration of ALTABAX.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ALTABAX and any potential adverse effects on the breastfed infant from ALTABAX or from the underlying maternal condition.

Geriatric Use

In this section, all instances of ‘studies’ are replaced by ‘trials’.

All instances of ‘patients’ are replaced by ‘subjects’.

Pediatric Use

In this section, all instances of ‘studies’ are replaced by ‘trials’.

All instances of ‘patients’ are replaced by ‘subjects’.