Animal & Veterinary

Phenylbutazone in Horses - Veterinarians

Issued: October 14, 2009
Reissued: March 4, 2016

Dear Equine 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 23 actively-marketed phenylbutazone products that are FDA-approved for use in horses (see addendum). These products are available in multiple dosage forms, including oral tablets, boluses, pastes, and powders; and solutions for intravenous injection. FDA wants to remind you of the benefits of using approved drugs in your practice.

Benefits of FDA Approval

FDA rigorously evaluates an animal drug before approving it. As part of the approval process, the drug company must prove to FDA that:

  • The drug is safe and effective for a specific use in a specific animal species;
  • The manufacturing process is adequate to preserve the drug’s identity, strength, quality, and purity; and
  • The drug’s labeling is truthful and not misleading.

FDA’s role does not stop after the agency approves an animal drug. As long as the drug company markets the animal drug, the agency continues to monitor:

  • The drug’s safety and effectiveness. Sometimes, the agency’s post-approval monitoring uncovers safety and effectiveness issues that were unknown at the time of approval;
  • The manufacturing process to ensure quality and consistency are maintained;
  • The drug’s labeling to make sure the information remains truthful and not misleading; and
  • The company’s marketing communications related to the drug to make sure the information is truthful and not misleading.

FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring that safe and effective drugs are available for animals. For more information, please contact CVM’s Education & Outreach Staff at 240-402-7002 or AskCVM@fda.hhs.gov.

Sincerely,

FDA’s Center for Veterinary Medicine

Addendum: FDA-Approved Phenylbutazone Products for Horses

All FDA-approved animal drugs have a New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number. The six-digit NADA or ANADA number and the statement “Approved by FDA” can usually be found on the drug’s label.

The same approved animal drug can be legally marketed under several labels. These different labels are made by the various companies that distribute the drug. Each distributor can use a different trade name for the drug. Therefore, under the same approved application (NADA or ANADA), several distributors can market a drug, each having a different trade name.

The following is a complete list of the actively-marketed, FDA-approved phenylbutazone products for horses as of February 26, 2016:

NADA number:  044-756
Sponsor:  Cross Vetpharm Group Ltd

DistributorTrade NameDosage Form
Bimeda IncBUTATRON TABLETSTablet

NADA number:  116-087
Sponsor:  Intervet Inc

DistributorTrade NameDosage Form
Burns Veterinary SupplyVETUS BUTAPASTEPaste
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE PASTEPaste
Intervet Inc doing business as Merck Animal HealthPHENYLZONE PASTE (6 g/syringe)Paste
Intervet Inc doing business as Merck Animal HealthPHENYLZONE PASTE
(12 g/syringe)
Paste
Vedco IncEQUI-PHAR BUTEPASTEPaste

ANADA number:  200-266
Sponsor:  Vetoquinol USA, Inc.

DistributorTrade NameDosage Form
Bioniche Animal Health USA, IncBUTEQUINE PASTEPaste
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE PASTEPaste
MWI Veterinary SupplyVETONE VETRIBUTEPaste
Vedco IncEQUI-PHAR BUTEPASTEPaste

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 POWDERPowder
MWI Veterinary SupplyVETONE PHENYLBUTAZONE POWDERPowder

ANADA number:  200-371
Sponsor:  Sparhawk Laboratories Inc

DistributorTrade NameDosage Form
Aspen Veterinary Resources LtdPHENYLBUTAZONE 20% INJECTIONSolution
Butler Animal Health Supply, LLC doing business as Henry Schein Animal HealthBUTAJECT PHENYLBUTAZONE INJECTION 200 MG/MLSolution
Clipper Distributing Company, LLC (Phoenix Pharmaceuticals)PHENYLBUTE INJECTION 20%Solution
MWI Veterinary SupplyVETONE PHENYLBUTAZONE 20% INJECTIONSolution
Sparhawk Laboratories IncPHENYLBUTAZONE 20% INJECTIONSolution
Vedco IncEQUI-PHAR PHENYLBUTAZONE 20% INJECTIONSolution

ANADA number:  200-433
Sponsor:  First Priority, Inc.

DistributorTrade NameDosage Form
Butler Animal Health Supply, LLC doing business as Henry Schein Animal HealthBUTATABS EBolus
First Priority, Inc.PRIORITY CARE PRIBUTAZONE BOLUSESBolus
MWI Veterinary SupplyVETONE VETRIBUTE BOLUSESBolus
Vedco IncBUTE BOLUSESBolus

 

Page Last Updated: 03/04/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.