Animal & Veterinary

Phenylbutazone in Horses - Pharmacy Professionals

October 16, 2009

Dear Pharmacy Professional:

Phenylbutazone is a non-steroidal anti-inflammatory drug commonly prescribed by veterinarians 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 drug’s identity, strength, quality, and purity are preserved.  The FDA continues to monitor the drug’s quality and safety after it is approved.

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, you may be asked to compound phenylbutazone for specific patients that require phenylbutazone in a strength or dosage form that is not available among the approved products.  In these instances, phenylbutazone can only be legally compounded if it is done by or on the order of a licensed veterinarian within the practice of veterinary medicine, and if an FDA-approved phenylbutazone product is used 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 drugs are available for veterinary use. 

For more information, please contact the Communications Staff at CVM at 240-276-9300 or AskCVM@fda.hhs.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

DistributorTrade NameDosage Form
Bimeda IncBUTATRON TABLETSTablet
MWI Veterinary SupplyVET ONE PHENYLBUTAZONE TABLETSTablet
Rx Veterinary ProductsPHENYLBUTAZONE TABLETS USPTablet

NADA number:  048-647
Sponsor:  First Priority Inc

DistributorTrade NameDosage Form
Clipper Distributing Company, LLC
(Phoenix Pharmaceuticals)
PHENYLBUTE BOLUSES 1 GRAMBolus
First Priority IncPRIORITY CARE PRIBUTAZONE TABLETSTablet
Pro Labs LtdPRO-BUTE TABLETSTablet
Rx Veterinary ProductsEQUI-BUTE PHENYLBUTAZONE BOLUSESBolus
Vedco IncBUTE TABSTablet

NADA Number:  091-818
Sponsor:  Teva Animal Health

DistributorTrade NameDosage Form
A & G PharmaceuticalsPHENYLBUTAZONE TABLETS, USPTablet
Butler Animal Health Supply, LLCBUTATABS E (PHENYLBUTAZONE TABLETS, USP) 1 GMTablet
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE TABLETSTablet
Pro Labs LtdPRO-BUTES TABLETSTablet
Rx Veterinary ProductsPHENYLBUTAZONE TABLETS, USP 1 GRAMTablet
Teva Animal Health IncAMTECH PHENYLBUTAZONE TABLETS, USPTablet
Vedco IncBUTE TABSTablet
Vet TekPHENYLBUTAZONE TABLETS, USPTablet

NADA number:  094-170
Sponsor:  Teva Animal Health

DistributorTrade NameDosage Form
Butler Animal Health Supply, LLCBUTATABS D PHENYLBUTAZONE TABLETS, USP 100MGTablet
Teva Animal Health IncAMTECH PHENYLBUTAZONE TABLETS, USP 100 MGTablet
Teva Animal Health IncAMTECH PHENYLBUTAZONE TABLETS, USP 200MGTablet

NADA number:  113-510
Sponsor:  Vetoquinol N A Inc

DistributorTrade NameDosage Form
N C N, IncEQUIPALAZONEPowder

NADA number:  116-087
Sponsor:  Intervet Inc

DistributorTrade NameDosage Form
Burns Veterinary SupplyVETUS BUTAPASTEPaste
Butler Animal Health Supply, LLCBUTAPASTEPaste
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE PASTEPaste
Schering-Plough Animal Health CorpPHENYLZONE PASTE (6 g/syringe)Paste
Schering-Plough Animal Health CorpPHENYLZONE PASTE (12 g/syringe)Paste
Vedco IncEQUI-PHAR BUTEPASTEPaste

NADA number:  140-958
Sponsor:  Luitpold Pharmaceuticals, Inc

DistributorTrade NameDosage Form
Luitpold Pharmaceuticals, IncEQUIPHEN PASTEPaste

ANADA number:  200-126
Sponsor:  Teva Animal Health

DistributorTrade NameDosage Form
A & G PharmaceuticalsPHENYLBUTAZONE 20% INJECTIONSolution
Aspen Veterinary Resources LtdPHENYLBUTAZONE INJECTION 20%Solution
Butler Animal Health Supply, LLCBUTAJECT PHENYLBUTAZONE INJECTIONSolution
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE INJECTION 20%Solution
Pro-Labs LtdPRO-BUTESolution
Rx Veterinary ProductsPHENYLBUTAZONE INJECTION 20%Solution
Teva Animal Health IncAMTECH PHENYLBUTAZONE 20% INJECTIONSolution
Vedco IncEQUI-PHAR PHENYLBUTAZONE INJECTIONSolution
Vet TekPHENYLBUTAZONE 20% INJECTIONSolution

ANADA number:  200-323
Sponsor:  West-Ward Pharmaceutical Corporation

DistributorTrade NameDosage Form
Apical Pharmaceutical CorporationBUPACTINTablet
West-Ward Pharmaceutical CorporationPHENYLBUTAZONE TABLETS 1 GMTablet
Xebec Pharmaceutical, IncPEGAPHENTablet

ANADA number:  200-333
Sponsor:  Superior Equine Pharmaceuticals, Inc

DistributorTrade NameDosage Form
Superior Equine Pharmaceuticals, IncSUPERIORBUTE POWDER WITH SWEET APPLE FLAVORPowder

ANADA number:  200-334
Sponsor:  A & G Pharmaceuticals Inc

DistributorTrade NameDosage Form
A & G PharmaceuticalsEQUIZONE 50/100 PHENYLBUTAZONE POWDER*Powder
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE POWDER*Powder

*Citrus-flavored

ANADA number:  200-371
Sponsor:  Sparhawk Laboratories Inc

DistributorTrade NameDosage Form
A & G PharmaceuticalsPHENYLBUTAZONE 20% INJECTIONSolution
Aspen Veterinary Resources LtdPHENYLBUTAZONE 20% INJECTIONSolution
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE INJECTION 20%Solution
Rx Veterinary ProductsPHENYLBUTAZONE 20% INJECTIONSolution
Sparhawk Laboratories IncPHENYLBUTAZONE 20% INJECTIONSolution
Vedco IncEQUI-PHAR PHENYLBUTAZONE 20% INJECTIONSolution

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