Robenacoxib Injection — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Robenacoxib Injection

Active ingredient

Robenacoxib

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

April 1, 2026

Adverse event reports

Source: openFDA VeDDRA

3,371

Reports mentioning this ingredient

April 9, 2011 – March 26, 2026

1,445

Classified serious

per reporter assessment

361

Lack of expected efficacy

resistance signal

15

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 “ROBENACOXIB”. 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
Lethargy (see also Central nervous system depression in 'Neurological')	297
Not eating	272
Lack of efficacy - NOS	253
Vomiting	229
Other abnormal test result NOS	221
Anorexia	214
Death by euthanasia	206
Fever	189
Behavioural disorder NOS	187
Weight loss	159
Lethargy (see also Central nervous system depression in Neurological)	157
Death	144
Elevated blood urea nitrogen (BUN)	136
Diarrhoea	131
Elevated creatinine	125
Decreased appetite	121
INEFFECTIVE, ANTIINFLAMMATORY	111
Dehydration	107
Underfilling, Package	103
Not drinking	103

Species affected

Source: openFDA VeDDRA

Cat 2,915 Dog 103 Human 7 Other Birds 2 Ferret 2 Rabbit 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

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