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.

NATACYN (NDA-050514)

(NATAMYCIN)

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

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11/17/2025 (SUPPL-22)

Approved Drug Label (PDF)

4 Contraindications

PLR conversion; please refer to label for complete information.

5 Warnings and Precautions

The following subsections created to comply with PLR; please refer to label for complete information.

5.1 Adherence to Epithelial Ulceration

5.2 Retention in Fornices

5.3 Risk of Contamination

Additions and/or revisions underlined:

Do not touch the dropper tip of the bottle to the eye, eyelids, or to any surface, as this may contaminate the contents. Use only if the container is undamaged.

5.4 Avoidance of Contact Lens Use

PLR conversion; please refer to label for complete information.

6 Adverse Reactions

6.2 Postmarketing Experience

Additions and/or revisions underlined:

The following adverse reactions have been identified during postapproval use of NATACYN. 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 reaction, change in vision, chest pain, corneal opacity, dyspnea, eye discomfort, eye edema, eye hyperemia, eye irritation, eye pain, foreign body sensation, paresthesia, and tearing.

8 Use in Specific Populations

8.1 Pregnancy

PLLR conversion:

Risk Summary

Animal reproduction studies have not been conducted with natamycin. It is also not known whether natamycin can cause fetal harm when administered to a pregnant patient or can affect reproduction capacity. NATACYN should be given to a pregnant patient only if clearly needed.

8.2 Lactation

PLLR conversion:

Risk Summary

It is not known whether natamycin is excreted in human milk. Caution should be exercised when NATACYN is administered to a nursing patient.

8.4 Pediatric Use

PLR conversion; please refer to label for complete information.

8.5 Geriatric Use

PLR conversion; please refer to label for complete information.

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

PATIENT COUNSELING INFORMATION

New section added to comply with PLR:

Risk of Contamination

Instruct patients to not touch the dropper tip to the eye, eyelids, or to any surface, as this may contaminate the contents. Advise patients to use the product only if the container is undamaged [see Warnings and Precautions (5.3)].

Contact Lens Wear

Advise patients to not wear contact lenses if they have signs and symptoms of fungal blepharitis, conjunctivitis, and keratitis. [see Warnings and Precautions (5.4)].

Other

Physician Labeling Rule (PLR) conversion.