DorajectTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

DorajectTM

Active ingredient

Doramectin

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

June 1, 2023

Adverse event reports

Source: openFDA VeDDRA

4,523

Reports mentioning this ingredient

October 16, 1996 – March 25, 2026

432

Classified serious

per reporter assessment

2,020

Lack of expected efficacy

resistance signal

293

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 “DORAMECTIN”. 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 (ectoparasite) - lice	1,086
Pruritus	548
Alopecia NOS	407
INEFFECTIVE, LICE BITING	372
Death	336
Unclassifiable adverse event	294
Accidental exposure	292
Lack of efficacy (lice)	277
Caps, Abnormal	264
Vials, Leaking	199
INEFFECTIVE, PARASITE(S) NOS	144
No sign	128
Lack of efficacy - NOS	122
INEFFECTIVE, WORMS NOS	110
INEFFECTIVE, LICE SUCKING	104
Lack of efficacy (ectoparasite) - mite NOS	99
Containers, Leaking	95
Closure, Abnormal	92
Lack of efficacy (ectoparasite) - NOS	88
Seal, Abnormal	87

Species affected

Source: openFDA VeDDRA

Cattle 3,085 Human 281 Pig 137 Dog 103 Cat 27 Sheep 24 Goat 24 Horse 12 Llama 5 Other 4 Buffalo 3 Alpaca 3

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