SolensiaTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

SolensiaTM

Active ingredient

Frunevetmab

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 14, 2026

Adverse event reports

Source: openFDA VeDDRA

7,813

Reports mentioning this ingredient

August 3, 2022 – March 26, 2026

4,500

Classified serious

per reporter assessment

982

Lack of expected efficacy

resistance signal

64

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 “FRUNEVETMAB”. 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
Skin scab	750
Vomiting	696
Lethargy (see also Central nervous system depression in Neurological)	597
Pruritus	556
Lack of efficacy - NOS	509
Weight loss	403
Death by euthanasia	395
Diarrhoea	373
Not eating	350
Skin lesion NOS	317
Partial lack of efficacy	311
Decreased appetite	291
Dermatitis	277
Anorexia	269
Death	258
Ataxia	240
Vocalisation	216
Itching	214
Scratching	213
Alopecia	194

Species affected

Source: openFDA VeDDRA

Cat 7,616 Human 81 Dog 6 Lynx 1 Other 1 Cougar 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