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.

SITAVIG (NDA-203791)

(ACYCLOVIR)

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

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12/18/2019 (SUPPL-1)

Approved Drug Label (PDF)

8 Use in Specific Populations

Lactation

(New subsection added)

There are no data on the presence of acyclovir in human milk following buccal administration. There are no data on the effects of acyclovir on the breastfed infant or milk production. Systemic exposure following buccal administration of acyclovir is minimal [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SITAVIG and any potential adverse effects on the breastfed child from SITAVIG or from the underlying maternal condition.

Pregnancy

(Additions and/or revisions underlined)

There are no available data on SITAVIG use in pregnant women. However, published observational studies over decades of use of acyclovir have not identified a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic exposure of acyclovir following buccal administration of SITAVIG is minimal [see Clinical Pharmacology (12.3)]. Animal reproduction studies have not been conducted with SITAVIG. Animal reproduction studies with systemic exposure of acyclovir have been conducted. Refer to oral and parental acyclovir prescribing information for additional details.

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

PATIENT COUNSELING INFORMATION

(Newly added information)

Inform patients that SITAVIG is not a cure for cold sores.

Patient Information

(Newly added information)

Talk to your healthcare provider about the best way to feed your baby during treatment with SITAVIG.