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Pure Lip Cold Sore Aids Promoted As "The Cold Sore Solution"

This article was originally published in The Tan Sheet

Executive Summary

Pure Lip Remedy and Prevention cold sore aids will be available in over 11,000 drugstore chains including Rite Aid, Walgreens, Albertsons, Eckerd and Longs Drug by the end of August.

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Avanir Abreva Cold Sore/Fever Blister Cream Approved By FDA

Avanir Pharmaceuticals' 10% docosanol cream was approved July 25 for the treatment of cold sores and fever blisters. The product, which FDA's approval letter indicates will be marketed as Abreva Cream, will be the first FDA-approved OTC cold sore and fever blister treatment.

SmithKline Beecham

Obtains exclusive U.S. and Canadian OTC marketing rights for Avanir Pharmaceuticals' 10% docosanol cream for herpes cold sores. In the first 12 months of the agreement, SmithKline will pay Avanir up to $25 mil., comprising an upfront licensing fee and milestone payments tied to product launch and sales performance. Avanir also will receive royalties on product sales. Avanir, which expects FDA action on its NDA by June 3, does not believe the agency's recent draft guidance disfavoring use of OTC antiviral treatments for herpes labialis will hinder agency approval because docosanol uses a different mechanism than the drugs FDA cited (1"The Tan Sheet" March 13, p. 3). The San Diego-based firm plans to initiate the OTC approval process in Canada this summer

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