"My horses love SUPERIORBUTE® POWDER'S sweet apple flavor. I have tried compounded imitations of the apple bute and my horses just flip me the bird."

J Bassett
All American Futurity winner

"I used an oral dosing syringe to bute my horse with SUPERIORBUTE® POWDER. It was so easy. I put a little bit of SUPERIORBUTE® POWDER on his tongue so he would be familiar with it then I..."

A Cromley

"Our clients like to use it because their horses eat it well. We prefer using the flavored SUPERIORBUTE® POWDER instead of regular phenylbutazone tablets."

H. Vaupel, DVM

24 Horse Cross Bio-equivalency Study Results (AUC 100.5% average of tablets)

Objective

The purpose of this study was to determine and compare the bioequivalence of the generic oral phenylbutazone product, SUPERIORBUTE POWDER, with a marketed reference (pioneer) Phenylbute tablets product.

Justification and Standards

Study Design

This was an in-vivo bioequivalency study of a generic version of phenylbutazone, SUPERIORBUTE POWDER. An in-vivo bioequivalency study was performed because it is accepted as the most sensitive procedure to assess the kenetics of systemic absorption of a generic drug relative to marketed products. This was a pivotal study intended to support FDA approval of this product as a generic drug intended for oral administration to horses.

Species

The study was performed in horses as they are the intended target species.

Route of Administration

The oral route was chosen because it is the intended route of administration to horses.

Dose Levels

Both the generic and pioneer test article products were delivered at an 8.8-mg/kg dosage.

Duration and Frequency of Dosing

Dosing occurred twice with a 14-day washout period between doses.

Standards

All portions of this study were performed according to the FDA Good Laboratory Practice Regulations currently in effect (21 CFR, Part 58), SBi standard operating procedures and the protocol.