Phenylbutazone in Horses, A Reminder For Veterinarians From the FDA

On Oct. 14, the FDA posted an open letter to veterinarians on its product safety Web site regarding the legal and illegal use of phenylbutazone. Included was a list of FDA-approved bute medications (listed below).

Here is the open letter:

Dear Veterinarian:

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 identity, 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, please contact the Communications Staff at CVM at 240/276-9300 or CVMHomeP@cvm.fda.gov.

Sincerely,

The FDA's Center for Veterinary Medicine


FDA-Approved Phenylbutazone Products for Horses

The following is a complete list of the actively-marketed FDA-approved phenylbutazone products for horses as of September 16, 2009. All FDA-approved products have a New Animal Drug Application (NADA) number, or for generic products, an Abbreviated New Animal Drug Application (ANADA) number. The six-digit (A)NADA number and the statement "Approved by FDA" can usually be found on the product label. The same product may be distributed by more than one company under different trade names. Several products may be marketed under one (A)NADA number.

 

NADA NUMBER: 044-756
Sponsor: Cross Vetpharm Group Ltd.
Distributor Trade Name Dosage Form
Bimeda Inc BUTATRON TABLETS Tablet
MWI Veterinary Supply VET ONE PHENYLBUTAZONE TABLETS Tablet
Rx Veterinary Products PHENYLBUTAZONE TABLETS USP Tablet

NADA NUMBER: 048-647
Sponsor: First Priority Inc.
Distributor Trade Name Dosage Form
Clipper Distributing Company LLC
(Phoenix Pharmaceuticals)
PHENYLBUTE BOLUSES 1 GRAM Bolus
First Priority Inc. PRIORITY CARE PRIBUTAZONE TABLETS Tablet
Pro Labs Ltd. PRO-BUTE TABLETS Tablet
Rx Veterinary Products EQUI-BUTE PHENYLBUTAZONE BOLUSES Bolus
Vedco Inc. BUTE TABS Tablet

NADA NUMBER: 091-818
Sponsor: Teva Animal Health
Distributor Trade Name Dosage Form
A&G Pharmaceuticals PHENYLBUTAZONE TALBETS, USP Tablet
Butler Animal Health Supply LLC BUTATABS E (PHENYLBUTAZONE TALBETS, USP) 1 GM Tablet
Clipper Distributing Company LLC (Phoenix Pharmaceuticals) PHENYLBUTE TABLETS Tablet
Pro Labs Ltd PRO-BUTES TABLETS Tablet
Rx Veterinary Products PHENYLBUTAZONE TABLETS, USP 1 Gram Tablet
Teva Animal Health Inc. AMTECH PHENYLBUTAZONE TABLETS, USP Tablet
Vedco Inc BUTE TABS Tablet
Vet Tek PHENYLBUTAZONE TABLETS, USP Tablet

NADA NUMBER: 094-170
Sponsor: Teva Animal Health
Distributor Trade Name Dosage Form
Butler Animal Health Supply LLC BUTATABS D PHENYLBUTAZONE TABLETS, USP 100MG Tablet
Teva Animal Health Inc. AMTECH PHENYLBUTAZONE TABLETS, USP 100 MG Tablet
Teva Animal Health Inc. AMTECH PHENYLBUTAZONE TABLETS, USP 200MG Tablet

NADA NUMBER: 113-510
Sponsor: Vetoquinol N A Inc.
Distributor Trade Name Dosage Form
N C N Inc. EQUIPALAZONE Powder

NADA NUMBER: 116-087
Sponsor: Intervet Inc.
Distributor Trade Name Dosage Form
Burns Veterinary Supply VETUS BUTAPASTE Paste
Butler Animal Health Supply LLC BUTAPASTE Paste
Clipper Distributing Company LLC
(Phoenix Pharmaceuticals)
PHENYLBUTE PASTE Paste
Schering-Plough Animal Health Corp. PHENYLZONE PASTE (6 g/syringe) Paste
Schering-Plough Animal Health Corp. PHENYLZONE PASTE
(12 g/syringe)
Paste
Vedco Inc. EQUI-PHAR BUTEPASTE Paste

NADA NUMBER: 140-958
Sponsor: Luitpold Pharmaceuticals Inc.
Distributor Trade Name Dosage Form
Luitpold Pharmaceuticals Inc. EQUIPHEN PASTE Paste

ANADA NUMBER: 200-126
Sponsor: Teva Animal Health
Distributor Trade Name Dosage Form
A&G Pharmaceuticals PHENYLBUTAZONE 20% INJECTION Solution
Aspen Veterinary Resources Ltd. PHENYLBUTAZONE INJECTION 20% Solution
Butler Animal Health Supply LLC BUTAJECT PHENYLBUTAZONE INJECTION Solution
Clipper Distributing Company LLC
(Phoenix Pharmaceuticals)
PHENYLBUTE INJECTION 20% Solution
Pro-Labs Ltd. PRO-BUTE Solution
Rx Veterinary Products PHENYLBUTAZONE INJECTION 20% Solution
Teva Animal Health Inc. AMTECH PHENYLBUTAZONE 20% INJECTION Solution
Vedco Inc. EQUI-PHAR PHENYLBUTAZONE INJECTION Solution
Vet Tek PHENYLBUTAZONE 20% INJECTION Solution

ANADA NUMBER: 200-323
Sponsor: West-Ward Pharmaceutical Corporation
Distributor Trade Name Dosage Form
Apical Pharmaceutical Corporation BUPACTIN Tablet
West-Ward Pharmaceutical Corporation PHENYLBUTAZONE TABLETS 1 GM Tablet
Xebec Pharmaceutical Inc. PEGAPHEN Tablet

ANADA NUMBER: 200-333
Sponsor: Superior Equine Pharmaceuticals Inc.
Distributor Trade Name Dosage Form
Superior Equine Pharmaceuticals Inc. SUPERIORBUTE POWDER WITH SWEET APPLE FLAVOR Powder

ANADA NUMBER: 200-334
Sponsor: A&G Pharmaceuticals Inc.
Distributor Trade Name Dosage Form
A&G Pharmaceuticals EQUIZONE 50/100 PHENYLBUTAZONE POWDER* Powder
Clipper Distributing Company LLC
(Phoenix Pharmaceuticals)
PHENYLBUTE POWDER* Powder

*Citrus-flavored

ANADA NUMBER: 200-371
Sponsor: Sparhawk Laboratories Inc.
Distributor Trade Name Dosage Form
A&G Pharmaceuticals PHENYLBUTAZONE 20% INJECTION Solution
Aspen Veterinary Resources Ltd. PHENYLBUTAZONE 20% INJECTION Solution
Clipper Distributing Company LLC (Phoenix Pharmaceuticals) PHENYLBUTE INJECTION 20% Solution
Rx Veterinary Products PHENYLBUTAZONE 20% INJECTION Solution
Sparhawk Laboratories Inc. PHENYLBUTAZONE 20% INJECTION Solution
Vedco Inc. EQUI-PHAR PHENYLBUTAZONE 20% INJECTION Solution

Disclaimer: Seek the advice of a qualified veterinarian before proceeding with any diagnosis, treatment, or therapy.

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