PANOQUELL®-CA1 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

PANOQUELL®-CA1

Active ingredient

Fuzapladib sodium

Application type

CNADA

Sponsor

Ishihara Sangyo Kaisha, Ltd.

Applications on record

1

First published

December 1, 2022

Adverse event reports

Source: openFDA VeDDRA

395

Reports mentioning this ingredient

February 26, 2022 – March 25, 2026

218

Classified serious

per reporter assessment

61

Lack of expected efficacy

resistance signal

10

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 “FUZAPLADIB SODIUM”. 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
Death by euthanasia	80
Lack of efficacy - NOS	53
Death	36
Abnormal ultrasound finding	34
Elevated total bilirubin	32
Anorexia	31
Vomiting	30
Icterus	27
Lethargy (see also Central nervous system depression in Neurological)	27
Elevated serum alkaline phosphatase (ALP)	26
Diarrhoea	22
Neutrophilia	22
Dehydration	22
Elevated alanine aminotransferase (ALT)	22
Anaemia NOS	21
Seizure NOS	20
Hyperglycaemia	19
Thrombocytopenia	19
Elevated blood urea nitrogen (BUN)	18
Abdominal pain	18

Species affected

Source: openFDA VeDDRA

Dog 369 Cat 3 Human 3

Regulatory context

Conditional approval (CNADA). Authorised under the Minor Use and Minor Species Animal Health Act of 2004. Conditional approval requires complete demonstration of safety and manufacturing consistency but permits commercial distribution on a reasonable expectation of effectiveness while confirmatory clinical trials are completed. CNADAs are granted for one-year terms, renewable up to five years.

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