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.