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OTC cimetidine

This article was originally published in The Tan Sheet

Executive Summary

Two new tentative ANDA approvals for the H2 antagonist allowed by FDA. Novopharm receives tentative approval for 200 mg cimetidine tablet May 28, while Lek Pharmaceutical receives tentative approval for cimetidine 100 mg and 200 mg tablets on the same day. Pioneer Tagamet marketer SmithKline Beecham initially introduced the OTC version in 100 mg tablets but launched a 200 mg tablet form in September 1996 and withdrew the 100 mg strength from sale in 1997. FDA, in the May 22 Federal Register, announces its determination the 100 mg dosage form sales withdrawal was not due to lack of safety or effectiveness, thereby allowing the approval of ANDAs for 100 mg tablets. Novopharm and Apotex submitted a citizen petition March 9 asking for the determination. Other generic drug firms with tentative ANDAs pending Tagamet's loss of marketing exclusivity June 19 are Perrigo, PFI and Granutec, all three of which began selling in their products to retailers late in 1998 ("The Tan Sheet" Nov. 17, 1997, p. 2)...
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