Tanoveatm — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Tanoveatm

Active ingredient

Rabacfosadine

Application type

NADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

March 3, 2022

Adverse event reports

Source: openFDA VeDDRA

335

Reports mentioning this ingredient

September 21, 2017 – March 3, 2026

196

Classified serious

per reporter assessment

139

Lack of expected efficacy

resistance signal

0

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 “RABACFOSADINE”. 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 (neoplasia, no remission)	66
Death by euthanasia	63
Diarrhoea	63
Lack of efficacy - NOS	56
Decreased appetite	36
Anorexia	35
Lethargy (see also Central nervous system depression in 'Neurological')	29
Weight loss	24
Death	20
Neutropenia	16
Vomiting	15
Pulmonary fibrosis	14
Nausea	14
Elevated alanine aminotransferase (ALT)	14
Cough	14
Bloody diarrhoea	12
Lethargy (see also Central nervous system depression in Neurological)	12
Hyperpigmentation	11
Erythema (for urticaria see Immune SOC)	11
Injection site complication NOS	10

Species affected

Source: openFDA VeDDRA

Dog 315 Human 3

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