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.

EDARBI (NDA-200796)

(AZILSARTAN KAMEDOXOMIL)

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

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01/16/2024 (SUPPL-13)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

(Additions and/or revisions underlined)

Safety and effectiveness in pediatric patients have not been established. Use of Edarbi is not recommended in children less than 2 years of age. It is not known whether post-natal use of azilsartan in patients less than 2 years of age, before maturation of kidney function is complete, has a long-term deleterious effect on the kidney.

Juvenile Animal Studies

In juvenile rat studies, dosing with azilsartan starting on post-natal day 14 (equivalent to a neonate with morphologically and functionally immature kidneys) resulted in increased incidence of edema of the renal papilla at the end of 4-week recovery period that was non-reversible. These findings occurred in the high-dose group (10 mg/kg) and were not observed in juvenile rats dosed starting on post-natal day 21 (equivalent to a human approximately 2 years of age) or adult rats.

10/24/2016 (SUPPL-9)

4 Contraindications

Do not coadminister aliskiren-containing products with Edarbi in patients with diabetes (addition underlined)

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

PATIENT COUNSELING INFORMATION

17.2 FDA-Approved Patient Labeling

What are the possible side effects of Edarbi?

Edarbi may cause side effects, including:

Harm or death to your unborn fetus if taken in the second or third trimester. See “What is the most important information I should know about Edarbi?”(addition underlined)