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FDA requests information on use of salicylates as OTC excipients in letter to P&G.

This article was originally published in The Tan Sheet

Executive Summary

FDA SEEKS INFORMATION ON USE OF SALICYLATES AS OTC EXCIPIENTS in a December letter to Procter & Gamble. FDA said it needs more information on "the use of salicylates as excipients in OTC drug products" to help the agency prepare a notice to extend the Reye syndrome warning that is currently required for aspirin-containing products to those products containing non-aspirin salicylates.

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