HeifermaX® 500 plus Bovatec® — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

HeifermaX® 500 plus Bovatec®

Active ingredient

Lasalocid Melengestrol Acetate

Application type

ANADA

Sponsor

Elanco US Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

251

Reports mentioning this ingredient

July 8, 2011 – October 15, 2024

127

Classified serious

per reporter assessment

125

Lack of expected efficacy

resistance signal

4

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 “LASALOCID SODIUM”. 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	72
Lack of efficacy (protozoa) - Coccidia	43
INEFFECTIVE, COCCIDIA	40
Lack of efficacy - NOS	35
Sudden death	12
Underdose	11
Ruminal bloat	9
No sign	9
Unexplained death	9
Overdose	7
Diarrhoea	7
Death by euthanasia	6
Accidental exposure	4
Product Defect, General	4
Incorrect dose administered NOS	4
Seizure NOS	4
Device Defective NOS	4
Unrelated death	4
Anorexia	3
Unable to stand	3

Species affected

Source: openFDA VeDDRA

Cattle 173 Horse 12 Turkey 10 Chicken 9 Sheep 7 Dog 5 Pig 3 Other Birds 3 Goat 2 Human 2 Rabbit 2 White tailed deer 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