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Pepcid AC Chewables Emphasize "Just One" Tablet Per Dose

This article was originally published in The Tan Sheet

Executive Summary

Directions for use of J&J/Merck's newly approved Pepcid AC Chewable famotidine specify "just one" tablet should be swallowed with water, according to labeling approved by FDA for the line extension. The product was green lighted by the agency Sept. 24 ("The Tan Sheet" Sept. 28, p. 18).

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Tagamet HB 200 Suspension Safety Data In Children Requested By FDA

FDA has asked SmithKline Beecham to conduct a "pharmacodynamic/safety study in pediatric subjects less than 12 years of age, if such data are not available," for Tagamet HB 200 suspension. The suspension form of the H2 antagonist cimetidine was approved July 9. SmithKline submitted NDA 20-951 Dec. 29, 1997.

Tagamet HB 200 Suspension Safety Data In Children Requested By FDA

FDA has asked SmithKline Beecham to conduct a "pharmacodynamic/safety study in pediatric subjects less than 12 years of age, if such data are not available," for Tagamet HB 200 suspension. The suspension form of the H2 antagonist cimetidine was approved July 9. SmithKline submitted NDA 20-951 Dec. 29, 1997.

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