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.

MEMBRANEBLUE (NDA-022278)

(TRYPAN BLUE)

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

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11/17/2025 (SUPPL-6)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.1 Excessive Staining

Additions and/or revisions underlined:

Excess MembraneBlue 0.15% should be immediately removed from the eye after staining.

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion:

Additions and/or revisions underlined:

Risk Summary

There are no available data on the use of MembraneBlue 0.15% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of MembraneBlue 0.15% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with MembraneBlue 0.15%, however, trypan blue has been shown to be teratogenic in various animal models at doses 323-fold and greater than the maximum recommended human dose, based on body surface area (BSA).

Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of MembraneBlue will result in fetal exposure to the drug and risk of teratogenic effects.

Data

Animal Data

Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat. Normalized to BSA, these doses are approximately 645- and 323-fold the maximum recommended human dose of 0.75 mg per injection (based on a 60 kg person), assuming complete systemic absorption of trypan blue. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 1,300-fold the maximum recommended human dose based on BSA, assuming complete systemic absorption).

8.2 Lactation

PLLR Conversion:

Risk Summary

The presence of trypan blue in human milk following intraocular administration of trypan blue has not been evaluated. There are no data available regarding the effects of trypan blue on milk production. Breastfeeding is not expected to result in exposure of the child to trypan blue due to the negligible systemic exposure of trypan blue in humans following injection and subsequent removal of the drug at the completion of surgical procedures.