PosilacTM — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

PosilacTM

Active ingredient

Bovine Somatotropin (Sometribove Zinc)

Application type

NADA

Sponsor

Union Agener, Inc.

Applications on record

1

First published

May 6, 2020

Adverse event reports

Source: openFDA VeDDRA

445

Reports mentioning this ingredient

May 11, 2011 – November 30, 2017

399

Classified serious

per reporter assessment

398

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 “BOVINE PARAINFLUENZA VIRUS 3 (TS), RLB103 (NL-BK-6), MLV; BOVINE RESPIRATORY SYN”. 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

Cattle 442

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