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Generic cimetidine

This article was originally published in The Tan Sheet

Executive Summary

Mylan receives first tentative ANDA for cimetidine 200, 300, 400 and 800 mg tablets -- the generic equivalent of SmithKline Beecham's ulcer drug Tagamet -- on Oct. 22. SmithKline does not lose patent protection on Tagamet until May 17, 1994. At an April 1991 presentation to securities analysts, SB said it planned a three-pronged strategy to extend the cimetidine franchise: an OTC version; line extensions; and finding partners to market the drug in generic versions. The firm said it is still in discussions with FDA about OTC cimetidine following a Sept. 9 FDA advisory committee meeting that concluded that the drug's efficacy in treating heartburn is not supported by data ("The Tan Sheet" Sept. 13, p. 1).
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