Albamast® Suspension — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Albamast® Suspension

Active ingredient

Novobiocin Sodium

Application type

NADA

Sponsor

Zoetis Inc.

Applications on record

1

First published

June 1, 2016

Adverse event reports

Source: openFDA VeDDRA

31

Reports mentioning this ingredient

May 6, 1998 – January 3, 2012

0

Classified serious

per reporter assessment

2

Lack of expected efficacy

resistance signal

2

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 “NOVOBIOCIN, PENICILLIN G PROCAINE”. 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
Residues in milk	6
Death	4
Underfilling, Package	3
Accidental exposure	2
Diarrhoea	2
Depression	2
Abortion	2
Tubes, Leaking	2
Underfilling, Tubes	2
No sign	2
Mastitis NOS	2
Caps, Abnormal	2
Mammary gland disorder NOS	2
Alteration of milk quality	2
Lack of efficacy - NOS	2
Seal, Abnormal	1
Anorexia	1
Physical label missing	1
Suspension, Abnormal	1
Tubes, Damaged	1

Species affected

Source: openFDA VeDDRA

Cattle 17 Goat 1

Regulatory context

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