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.

COSOPT PF (NDA-202667)

(DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE)

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

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04/09/2026 (SUPPL-5)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.1 Pregnancy

PLLR Conversion

Risk Summary

There are no adequate and well-controlled studies of COSOPT PF in pregnant women to inform a drug-associated risk. No evidence of teratogenicity has been observed in mice, rat, and rabbits with dorzolamide hydrochloride or timolol at clinically relevant doses [see Data].

Data

Animal Data

Oral administration of dorzolamide hydrochloride in pregnant rabbits at oral doses of greater than or equal to 2.5 mg/kg/day (31 times the recommended human ophthalmic dose) revealed malformations of the vertebral bodies. These malformations occurred at doses that caused metabolic acidosis with decreased body weight gain in dams and decreased fetal weights. No treatment-related malformations were seen at 1 mg/kg/day (13 times the recommended human ophthalmic dose).

Oral administration of timolol in pregnant mice, rats and rabbits at does up to 50 mg/kg/day (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose) demonstrated no evidence of fetal malformations. Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1,000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions.

Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose, in this case without apparent maternotoxicity.

8.2 Lactation

PLLR Conversion

Risk Summary

It is not known whether dorzolamide hydrochloride and timolol are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when COSOPT PF is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COSOPT PF and any potential adverse effects on the breastfed child from COSOPT PF.

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

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined:

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

. . .

PATIENT INFORMATION

Additions and/or revisions underlined:

COSOPT®PF (CO-sopt PEA EHF)

(dorzolamide hydrochloride and timolol maleate ophthalmic solution) 2%/0.5% For topical ophthalmic use

. . .

What should I tell my healthcare provider before using COSOPT PF? Before you use COSOPT PF, tell your healthcare provider if you:

. . .

are breastfeeding or plan to breastfeed. It is not known whether dorzolamide or timolol passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use COSOPT PF.

. . .