Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

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.

YORVIPATH (NDA-216490)

(PALOPEGTERIPARATIDE)

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

Download Data

Expand all

08/03/2026 (SUPPL-11)

Approved Drug Label (PDF)

4 Contraindications

Additions and/or revisions underlined:

YORVIPATH is contraindicated in patients with a history of severe hypersensitivity to palopegteriparatide or any of the inactive ingredients of YORVIPATH. Reactions have included anaphylaxis, angioedema, and urticaria.

5 Warnings and Precautions

5.1 Hypersensitivity Reactions

Newly added subsection:

Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria have been reported in patients treated with parathyroid hormone (PTH) analogs, including YORVIPATH [see Adverse Reactions (6.2)]. If signs or symptoms of a hypersensitivity reaction occur, discontinue treatment with YORVIPATH, initiate appropriate supportive care, and monitor until signs and symptoms resolve. Discontinue YORVIPATH permanently in patients with a severe hypersensitivity reaction to YORVIPATH. YORVIPATH is contraindicated in patients with a history of severe hypersensitivity to palopegteriparatide or any of the inactive ingredients of YORVIPATH [see Contraindications (4)].

6 Adverse Reactions

Addition of the following to the bulleted line listing:

Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

6.2 Postmarketing Experience

Newly added subsection:

The following adverse reactions have been identified during post-approval use of YORVIPATH. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic reactions: Anaphylaxis, angioedema, drug hypersensitivity, urticaria

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

MEDICATION GUIDE

Additions and/or revisions underlined:

What is the most important information I should know about YORVIPATH? YORVIPATH may cause serious side effects, including:

Allergic (hypersensitivity) reactions, including anaphylaxis. Stop taking YORVIPATH and get medical help right away if you have any of the following symptoms of an allergic reaction:

…

Who should not take YORVIPATH? Do not use YORVIPATH if you:

have had a severe allergic reaction to palopegteriparatide or any of the other ingredients in YORVIPATH. Ask your health care provider if you are not sure. See the end of this Medication Guide for a complete list of ingredients in YORVIPATH.

…

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

…

Hypersensitivity Reactions

Advise patients that serious hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria, can occur with YORVIPATH. Advise patients to discontinue YORVIPATH and promptly seek medical attention if signs or symptoms of hypersensitivity reactions occur [see Contraindications (4) and Warnings and Precautions (5.1)].

…