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GUIDANCE DOCUMENT

CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals January 2006

Download the Final Guidance Document
Final
Docket Number:
FDA-2004-D-0372
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance document provides CVM’s recommendations on approaches for developing target animal safety and effectiveness data to support approval of veterinary non-steroidal anti-inflammatory drugs (NSAIDs) -- specifically, approval of NSAIDs that reduce the production of prostaglandins by inhibiting the cyclo-oxygenase (COX) pathway. These recommendations are based on the premise that NSAIDs are not tissue-specific, and important clinical effects associated with toxicity of NSAIDS frequently manifest themselves in the gastrointestinal and renal systems.

In addition, alternative strategies for generating safety and effectiveness data for NSAIDs that inhibit lipo-oxygenase, or both lipo-oxygenase and cyclo-oxygenase, or act as cytokine antagonists may be appropriate.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2004-D-0372.

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