SmithKline Beecham Continues To Pursue Denavir Switch
This article was originally published in The Tan Sheet
Executive Summary
SmithKline Beecham "will continue to work with the FDA to resolve" issues raised in a "not approvable" letter from the agency for the company's Rx-to-OTC switch application of Denavir. The topical 1% penciclovir cream is indicated for the treatment of cold sores, or herpes labialis, in immunocompetent adults.
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