AGRIMYCIN®-343 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

AGRIMYCIN®-343

Active ingredient

Oxytetracycline Hydrochloride

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

1

First published

July 2, 2018

Adverse event reports

Source: openFDA VeDDRA

432

Reports mentioning this ingredient

January 22, 1987 – August 11, 2022

5

Classified serious

per reporter assessment

42

Lack of expected efficacy

resistance signal

25

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 “OXYTETRACYCLINE HYDROCHLORIDE”. 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
No sign	94
Color, Abnormal	64
Death	58
Granules/Powder, Abnormal	37
Lack of efficacy (bacteria) - NOS	34
Residues in eggs	33
Accidental exposure	25
Seal, Abnormal	25
Unclassifiable adverse event	22
Solution, Abnormal	20
Odor, Abnormal	19
Containers, Damaged	17
Anaphylaxis	14
Residues in meat/offal	14
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	11
Vials, Leaking	10
Product Defect, General	9
Recumbency	8
Suspension, Abnormal	8
Lack of efficacy - NOS	7

Species affected

Source: openFDA VeDDRA

Chicken 141 Cattle 59 Human 25 Other Birds 17 Sheep 8 Other 8 Horse 7 Dog 7 Pig 4 Fish 3 Rabbit 3 Goat 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