Issue Date: January 5, 2006
Issued by: Center for Veterinary Medicine
Topic(s): Target Animal – Effectiveness, Target Animal – Safety
Status: Final
CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in Animals
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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