Solu-Pen — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Solu-Pen

Active ingredient

Penicillin G Potassium

Application type

ANADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

May 19, 2017

Adverse event reports

Source: openFDA VeDDRA

27

Reports mentioning this ingredient

November 20, 2003 – August 18, 2023

6

Classified serious

per reporter assessment

3

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 “PENICILLIN G POTASSIUM”. 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
Solution, Abnormal	3
Granules/Powder, Abnormal	2
Lack of efficacy (bacteria) - NOS	2
Containers, Damaged	2
Containers, Leaking	2
Partial adipsia	2
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	1
Agitation	1
Anaphylaxis	1
Ataxia	1
Hyperhidrosis	1
Tachycardia	1
Tachypnoea	1
Malaise	1
Convulsion	1
Death	1
Underfilling, Package	1
Underfilling, Container	1
Difficulty of Use	1

Species affected

Source: openFDA VeDDRA

Dog 6 Horse 5 Pig 3 Cat 2 Turkey 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