Albac® 50 Type A Medicated Article — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Albac® 50 Type A Medicated Article

Active ingredient

Bacitracin Zinc

Application type

ANADA

Sponsor

Zoetis Inc.

Applications on record

2

First published

June 1, 2016

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200223	ANADA	Approved	—
98452	NADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

1

Reports mentioning this ingredient

January 13, 2020 – January 13, 2020

1

Classified serious

per reporter assessment

0

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 “BACITRACIN ZINC”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Species affected

Source: openFDA VeDDRA

Cat 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.

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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