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.

NAFTIN (NDA-019599)

(NAFTIFINE HYDROCHLORIDE)

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

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11/10/2016 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Local Adverse Reactions

Discontinue treatment if irritation or sensitivity develops with the use of NAFTIN Cream. Direct patients to contact their physician if these conditions develop following use of NAFTIN Cream. (Additions and/or revisions underlined)

6 Adverse Reactions

6.1 Clinical Trials Experience

During clinical trials, 903 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 564 subjects with interdigital tinea pedis, tinea cruris, or tinea corporis were treated with NAFTIN Cream.

… In a third randomized, vehicle-controlled trial, 116 pediatric subjects with tinea corporis were treated with NAFTIN Cream. The population was aged ?2 to <18 years (mean age of 9 years), predominantly male (61%), 47% White, 51% Black or African American, 92% Hispanic or Latino, and infected with tinea corporis. NAFTIN Cream was topically applied once daily for 2 weeks to all affected body surface areas with tinea corporis plus a ½ inch margin of healthy skin surrounding the affected lesions. The incidence of adverse reactions in the NAFTIN Cream treated population was not significantly different than in the vehicle treated population.

. In two open-label pediatric pharmacokinetics and safety trials, 49 pediatric subjects 2 to less than 18 years of age with interdigital tinea pedis, tinea cruris, and tinea corporis received NAFTIN Cream…

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion:

Risk Summary

There are no available data with NAFTIN Cream in pregnant women to inform the drug-associated risk for major birth defects and miscarriage. In animal reproduction studiesa, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 18 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 2 times the MRHD in pregnant rats or 4 times the MRHD in pregnant rabbits.

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

Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses based on body surface area comparison (mg/m2), the MRHD is set at 8 g 2% cream per day (2.67 mg/kg/day for a 60 kg individual).

Oral doses of 30, 100 and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment- related effects on embryofetal development were noted at doses up to 300 mg/kg/day ( 18 times MRHD). Subcutaneous doses of 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats. No treatment-related effects on embryofetal development were noted at 30 mg/kg/day (2 times MRHD). Subcutaneous doses of 3, 10 and 30 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to 18 pregnant female rabbits. No treatment related effects on embryofetal development were noted at 30 mg/kg/day ( 4 times MRHD).

A peri- and post-natal development study was conducted in rats. Oral doses of 30, 100 and 300 mg/kg/day naftifine hydrochloride were administered to female rats from gestational day 14 to lactation day 21. Reduced body weight gain of females during gestation and of the offspring during lactation was noted at 300 mg/kg/day (18 times MRHD). No developmental toxicity was noted at 100 mg/kg/day ( 6 times MRHD).

8.2 Lactation

PLLR Conversion:

Risk Summary

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

8.4 Pediatric Use

The safety and effectiveness of NAFTIN Cream have been established in pediatric patients age 12 and above with interdigital tinea pedis and tinea cruris and age 2 and above with tinea corporis.

Use of NAFTIN Cream in these age groups is supported by evidence from adequate and well controlled studies in adults and children, with additional safety and PK data from two open label trials conducted in 49 pediatric subjects exposed to NAFTIN Cream.

Safety and effectiveness of Naftin Cream in the treatment of tinea cruris and interdigital tinea pedis in pediatric patients less than 12 years of age have not been established. Safety and effectiveness of Naftin Cream in the treatment of tinea corporis in pediatric patients less than 2 years of age have not been established.