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.

ULESFIA (NDA-022129)

(BENZYL ALCOHOL)

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

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04/26/2020 (SUPPL-8)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

(PLLR conversion)

Risk Summary

Rare pregnancy outcomes reported in the published literature with benzyl alcohol use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, maternal use is not expected to result in fetal exposure to the drug.

In animal reproduction studies, subcutaneous administration of benzyl alcohol to pregnant rats and rabbits during organogenesis did not cause any malformations (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of benzyl alcohol observed in animal studies to the systemic exposure that would be expected in humans after topical use of ULESFIA Lotion.

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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively

Data

Animal Data

In embryo-fetal development studies, pregnant rats and rabbits received subcutaneous doses of benzyl alcohol during organogenesis at doses up to 500 mg/kg/day and 400 mg/kg/day, respectively. There were no malformations noted in either species. In rats, maternal toxicity and decreased fetus weight occurred at 500 mg/kg/day. In rabbits, maternal toxicity occurred at 250 and 400 mg/kg/day and was associated with decreased fetal weight at 400 mg/kg/day.

8.2 Lactation

(PLLR conversion)

Risk Summary

There is no information available on the presence of benzyl alcohol in human or animal milk, the effects of the drug on breastfed infant, or the effects of the drug on milk production. When used as prescribed, topical benzyl alcohol is unlikely to be absorbed through the skin in clinically relevant amounts; therefore, breastfeeding is not expected to result in exposure of the infant to ULESFIA Lotion. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ULESFIA Lotion and any potential adverse effects on the breastfed infant from ULESFIA Lotion or from the underlying maternal condition.

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

PATIENT INFORMATION

(additions underlined)

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Before you use ULESFIA Lotion, tell your healthcare provider if you:

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are breastfeeding. It is not known if ULESFIA Lotion passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using ULESFIA Lotion.

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