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.

IDOSE TR (NDA-218010)

(TRAVOPROST)

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

Download Data

01/27/2026 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.3 Patients without Baseline Corneal Endothelial Cell Density Prior to Initial Administration

Newly added subsection

It is not recommended to readminister iDose TR if baseline central corneal endothelial cell density was not established prior to initial administration of iDose TR [see Warnings and Precautions (5.4, 5.5)].

5.4 Recommended Minimum Corneal Endothelial Cell Density for Readministration

Newly added subsection

Central corneal endothelial cell density should not be less than the recommended minimum listed in Table 2 prior to the initial administration of iDose TR and prior to each readministration.

If corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye was implanted, corneal endothelial cell density in the un-implanted contralateral eye meeting the recommended minimum density may be used for eligibility determination for readministration of iDose TR (see Table 2).

Table 2: Recommended Minimum Central Corneal Endothelial Cell Density

Newly added table; please refer to label for complete information.

5.5 Corneal Endothelial Cell Loss

Newly added subsection

iDose TR should be readministered with caution in eyes with 10% or greater loss in central corneal endothelial cell density from pre-administration baseline (adjusted for age-related 1% loss per year and for a 10% loss following an anterior segment surgical procedure [i.e., cataract surgery]).

If baseline corneal endothelial cell density was not established prior to the initial administration of iDose TR and only a single eye is implanted, a 10% threshold level of endothelial cell density loss as a difference of the implanted eye versus un-implanted contralateral eye should be considered before readministering iDose TR.