LibrelaTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

LibrelaTM

Active ingredient

Bedinvetmab

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

February 19, 2025

Adverse event reports

Source: openFDA VeDDRA

18,904

Reports mentioning this ingredient

June 14, 2023 – March 27, 2026

11,649

Classified serious

per reporter assessment

2,230

Lack of expected efficacy

resistance signal

136

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 “BEDINVETMAB”. 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	1,886
Lethargy (see also Central nervous system depression in Neurological)	1,786
Polydipsia	1,393
Ataxia	1,336
Polyuria	1,294
Seizure NOS	1,274
Vomiting	1,214
Diarrhoea	1,184
Urinary incontinence	1,167
Death	1,047
Limb weakness	931
Partial lack of efficacy	923
Lack of efficacy - NOS	899
Not eating	789
Urinary tract infection	785
Panting	744
Unable to walk	680
Decreased appetite	663
Anorexia	650
Proprioception deficit	623

Species affected

Source: openFDA VeDDRA

Dog 18,645 Human 130 Cat 8 Other Canids 4

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