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Zovirax OTC switch

This article was originally published in The Tan Sheet

Executive Summary

Supplemental NDA for OTC oral acyclovir use for prevention of genital herpes outbreaks will be filed this summer, Burroughs Wellcome VP-Research David Barry reports at the firm's May 5 R&D conference in New York. The company reported earlier this year that it was on track to file for the Zovirax switch by the end of 1993 ("The Tan Sheet" March 29, p. 1). The antiviral agent already is sold over-the-counter in topical form in several European countries. The U.S. patent for Zovirax expires in April 1997. The company also reported that it is working on an NDA for a second generation acyclovir product, valaciclovir, which will be submitted to FDA in 1994 as a prescription drug for treating herpes simplex and herpes zoster.
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