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In Brief: SmithKline Beecham's Tagamet HB

This article was originally published in The Tan Sheet

Executive Summary

SmithKline Beecham's Tagamet HB: OTC version of cimetidine is "approvable" at FDA as of June 13. The milestone moves Tagamet closer to becoming the second H2 antagonist approved for OTC use. J&J-Merck's Pepcid AC cleared FDA in April and entered the market in early June. Tagamet HB was recommended for approval by an FDA advisory committee in March. Approval is expected imminently...
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