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U.S. Department of Health and Human Services

Animal & Veterinary

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Draft Guidance for Drug Sponsors on NSAIDs for Use in Animals Available for Review and Comment

November 10, 2004

FDA is announcing the availability for comment of draft guidance for industry entitled, “Development of Target Animal Safety and Effectiveness Data to Support Approval of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for Use in Animals” (Guidance 123.)  This draft guidance provides recommended approaches for drug sponsors on the development of target animal safety and effectiveness data to support approval of veterinary NSAIDs that reduce the production of prostaglandins by inhibiting the cyclooxygenase (COX) pathway.  Recommendations in this draft guidance are based on the premise that NSAIDs are not tissue-specific and important clinical effects associated with toxicity of NSAIDs are frequently manifested in the gastrointestinal and/or renal systems.

FDA's Center for Veterinary Medicine (CVM) recommends that drug sponsors discuss their product development plan and study protocols with CVM before they initiate any studies that may be used to support approval.  CVM may recommend alternative product development strategies for NSAIDs that inhibit lipooxygenase, or both lipooxygenase and cyclooxygenase, or act as cytokine antagonists.  FDA recommends that sponsors contact CVM to discuss which recommendations in this draft guidance may be applicable to the development of such drugs. 

Draft Guidance #123 is posted on the CVM Home Page.  Single copies of the guidance may be obtained by writing to the Communications Staff, FDA/Center for Veterinary Medicine, 7519 Standish Place, HFV-12, Rockville, MD 20855, 301-827-3800.  Please send one self-addressed adhesive label to assist in processing your request.

Comments and suggestions regarding this draft guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.  All comments should be identified with Docket number 2004D-0468.  Comments may also be submitted electronically via the Internet.  Comments on draft Guidance #123 should be submitted by January 24, 2005, to ensure their adequate consideration in preparation of the final document.  General comments on agency guidance documents are welcome at any time.

Additional information about this draft guidance document may be found in the November 10, 2004 , Federal Register. Questions regarding this document may be directed to Dr. Linda Wilmot, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Place , Rockville , MD 20855 , 301-827-0135, e-mail: mailto:lwilmot@cvm.fda.gov.

This draft guidance, when finalized, will represent the Food and Drug Administration's current thinking on the development of target animal safety and effectiveness data to support approval of non-steroidal anti-inflammatory drugs for use in animals.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  Drug sponsors may use an alternative approach if the approach satisfies the requirements of applicable statutes and regulations.


Contact FDA

240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855