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Avanir

This article was originally published in The Tan Sheet

Executive Summary

Company signs a letter of intent with SmithKline Beecham giving SB the rights to market docosanol 10% cream as an OTC treatment for cold sores. Avanir Pharmaceuticals originally intended to market the product as an Rx drug but was told by FDA the product would be more appropriate OTC ("The Tan Sheet" Nov. 8, 1999, p. 6). The company is awaiting NDA approval. The deal, announced Dec. 21, might mark a new direction for SmithKline in its attempt to enter the OTC category. SB attempted to switch Rx cold sore treatment Denavir (penciclovir 1%) in December 1998, but FDA's Antiviral and Nonprescription Drugs Advisory Committees voted against OTC status due to fears of increased viral resistance
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