Serving the Professional Equine Practitioner
Equizone 100 was the FIRST FDA approved phenylbutazone powder on the market. A palatable bute ( citrus flavored) powder approved for oral use in horses by the FDA. (U.S. Patent # 6,552,063 B2).
Equizone 100 and Equizone 50 are both made from all natural sweetners, no artificial sweeteners added.
Don't be fooled:
***November 2005, A & G Pharmaceuticals Inc, was pleased to announce our FDA approval on Equizone 100.
***November 2008, A & G Pharmaceuticals Inc, is pleased to introduce our newest member of the Equizone family. EQUIZONE 50 (phenylbutazone powder). Our same palatable flavored bute, available in a 50gram container. (1.1 pound)
***Both Equizone 100 and Equizone 50 mask the bitterness of the phenylbutazone using only natural sweeteners. No artificial sweeteners are added.
***Both Equizone 100 and Equizone 50 are FDA approved.
A & G Pharmaceuticals is dedicated to serving the Professional Equine Practitioner. We sell only to licensed veterinarians. We have a wide arrange of products to help you in your equine veterinary practice.
A & G Pharmaceuticals Inc. received our FDA approval on Equizone 100, Phenylbutazone Powder in November of 2005. To view the Freedom of Information Summary on Equizone 100, click on this link provided by the FDA.
Phenylbutazone in Horses
As you know, phenylbutazone is a non-steroidal anti-inflammatory drug commonly used for the relief of inflammatory conditions associated with the musculoskeletal system in horses. There are 48 actively-marketed phenylbutazone products that are approved by the U.S. Food and Drug Administration (FDA) for use in horses (please refer to the complete product list below). These products are available in multiple dosage forms, including oral tablets, boluses, pastes, and powders; and solutions for intravenous injection. Two of the approved powders are flavored for use in feed.
Each FDA-approved animal drug goes through a rigorous evaluation process, and prior to approval, is clinically tested for safety and effectiveness in the target animal species. In addition, the FDA thoroughly inspects and evaluates the adequacy of the manufacturing process to ensure that the product’s indentity, strength, quality, and purity are preserved. The FDA continues to monitor the product’s quality and safety after it is approved.
In prescribing an FDA-approved phenylbutazone product, you are providing your clients and their horses with a drug that has demonstrated safety and effectiveness in horses and whose manufacturing process met the FDA’s standards for quality, purity, and potency.
The numerous FDA-approved phenylbutazone products for horses, available in multiple dosage forms and two flavors, greatly reduce the need for compounding. In very limited cases when you have specific patients that require phenylbutazone in a strength or dosage form that is not available among the approved products, phenylbutazone can only be legally compounded by using an FDA-approved phenylbutazone product as the starting material. Phenylbutazone should not be compounded from bulk. An animal drug that is compounded from bulk drug ingredients is not FDA-approved, and therefore, the safety and effectiveness of the compounded drug, as well as the adequacy of the manufacturing process, have not been evaluated.
The requirements for legal animal drug compounding can be found in Title 21, Code of Federal Regulations, Section 530.13.
At the FDA’s Center for Veterinary Medicine (CVM), we are committed to promoting and protecting animal health by ensuring that safe and effective products are available for veterinary use.
For more information:
CVM Communications Staff
P: 240-276-9300 or F: 240-276-9115
The FDA's Center for Veterinary Medicine