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Private label cimetidine

This article was originally published in The Tan Sheet

Executive Summary

Novopharm receives approval June 19 for 200 mg cimetidine tablets comparable to SmithKline Beecham's Tagamet HB 200, the same day exclusivity expires for the Rx-to-OTC switch H2 antagonist. Novopharm's Granutec subsidiary is packaging the product under store brands to ship nationwide immediately. Novopharm received tentative ANDA approval at the beginning of the month, as did Lek Pharmaceuticals ("The Tan Sheet" June 1, In Brief). Other companies seeking approval for private label cimetidine include Perrigo, Pharmaceutical Formulations, Inc. and Leiner Health Products. Leiner is marketing the product under an agreement with Lek ("The Tan Sheet" June 8, In Brief). Private labelers began promoting cimetidine to the trade in fall 1997 ("The Tan Sheet" Nov. 17, 1997, p. 12)...
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