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Pepcid AC

This article was originally published in The Tan Sheet

Executive Summary

Merck Chairman and CEO Ray Gilmartin tells New York analysts that the company is confident that an OTC version of the anti-ulcer drug famotidine will be approved by FDA next year. Speaking at a Nov. 29 meeting of the New York Society of Securities Analysts, Gilmartin said the company has "resolved some issues with the FDA [and is] confident of U.S. approval...timely enough that would allow us to have sales in 1995." He added, however, that "given the launch expenses combined with the sales, we wouldn't really expect any material effect on any contribution to earnings" in 1995. A joint FDA advisory committee recommended in July that J&J-Merck, which will market Pepcid AC, needs to resolve several statistical issues related to the company's efficacy studies before the drug can be approved (The Tan Sheet" Aug. 1, p. 1)
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