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Watson Seeking FDA Clarification On Nicotine Gum User Guide, Cassette

This article was originally published in The Tan Sheet

Executive Summary

Watson Pharmaceuticals has contacted FDA seeking clarification on how similar its generic nicotine gum's user guide and audiocassette must be to those that are sold with the innovator product, SmithKline Beecham's Nicorette.

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SmithKline v. Watson

At a Sept. 9 preliminary injunction hearing in Manhattan federal court, Watson Pharmaceuticals agree to suspend further shipments of its OTC generic nicotine gum until Sept. 16 or until Judge Dennis Chin reaches a decision in the copyright infringement suit recently filed by SmithKline Beecham Consumer Healthcare, whichever comes first. The private label company also agree to contact retailers that already have received shipments to instruct them not to sell the gum before Sept. 16 or the date the decision is reached. If Judge Chin fails to decide the case by Sept. 16, the agreement will be reevaluated. The Aug. 26 suit alleges the audiotape and user's guide accompanying the generic smoking cessation gum violate the copyright of SmithKline's Nicorette materials (1"The Tan Sheet" Sept. 6, p. 3)

SmithKline Seeks Injunction Against Watson Nicotine Gum Labeling

SmithKline Beecham Consumer Healthcare alleges copyright infringement of the company's Nicorette smoking cessation gum in a lawsuit filed against Watson Pharmaceuticals and its subsidiaries, Watson Laboratories and Circa Pharmaceuticals, Aug. 26.





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