Posatex® Otic Suspension — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Posatex® Otic Suspension

Active ingredient

Mometasone Furoate Monohydrate Orbifloxacin posaconazole

Application type

NADA

Sponsor

Intervet, Inc.

Applications on record

1

First published

March 23, 2020

Adverse event reports

Source: openFDA VeDDRA

94

Reports mentioning this ingredient

December 14, 2011 – February 23, 2026

27

Classified serious

per reporter assessment

28

Lack of expected efficacy

resistance signal

1

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “MOMETASONE FUROATE MONOHYDRATE + ORBIFLOXACIN + POSACONAZOLE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Lack of efficacy - NOS	2
Anorexia	2
Lethargy (see also Central nervous system depression in Neurological)	2
Vomiting	2
Granuloma	1
Neurogenic keratoconjunctivitis sicca (KCS)	1
Palpebral disorder NOS	1
Cloudy eye (for Miosis, Mydriasis, Anisocoria, Nystagmus - see 'Neurological')	1
Third eyelid protrusion	1
Corneal ulcer	1
Other abnormal test result NOS	1
Facial paralysis	1
Nasal discharge	1
Ocular discharge	1
Stenotic ear canal	1
Discomfort NOS	1
Skin slough	1
Eye disorder NOS (for photophobia see 'neurological')	1
Corneal disorder NOS	1
Anisocoria	1

Species affected

Source: openFDA VeDDRA

Dog 92 Cat 2

Regulatory context

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient