Mitaban® Liquid Concentrate — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Mitaban® Liquid Concentrate

Active ingredient

Amitraz

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

1,090

Reports mentioning this ingredient

February 12, 1987 – March 13, 2023

37

Classified serious

per reporter assessment

103

Lack of expected efficacy

resistance signal

80

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 “AMITRAZ”. 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
Depression	267
Vomiting	149
Unclassifiable adverse event	121
Ataxia	93
Death	83
Anorexia	81
Accidental exposure	80
Lack of efficacy (ectoparasite) - Demodex	79
Vials, Leaking	67
Sedation	65
Pruritus	65
Convulsion	58
Diarrhoea	57
Skin hyperaemia	43
Rash	40
Caps, Abnormal	35
Fever	34
Lethargy (see also Central nervous system depression in 'Neurological')	34
Weakness	28
Hypothermia	26

Species affected

Source: openFDA VeDDRA

Dog 845 Human 131 Cat 4 Other 2 Fish 1

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