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Tagamet HB 200 Suspension Safety Data In Children Requested By FDA

This article was originally published in The Tan Sheet

Executive Summary

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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Tagamet HB 200 Liquid

National TV advertising breaks June 5 for first OTC liquid H2 antagonist. SmithKline Beecham's Tagamet HB extension launched in April (1"The Tan Sheet" May 15, p. 4). FSIs with a $2-off coupon for any size liquid and a $1 coupon for 12-count tablets will continue to be distributed throughout the year, accompanied by in-store promotions and $5 rebate coupons available with product on retail shelves, SB says. Product employs an accordion-style label in order to fit all necessary instructions and warnings (2"The Tan Sheet" July 19, 1999, p. 5)

Tagamet HB 200 Liquid

National TV advertising breaks June 5 for first OTC liquid H2 antagonist. SmithKline Beecham's Tagamet HB extension launched in April (1"The Tan Sheet" May 15, p. 4). FSIs with a $2-off coupon for any size liquid and a $1 coupon for 12-count tablets will continue to be distributed throughout the year, accompanied by in-store promotions and $5 rebate coupons available with product on retail shelves, SB says. Product employs an accordion-style label in order to fit all necessary instructions and warnings (2"The Tan Sheet" July 19, 1999, p. 5)

Tagamet HB 200 Liquid

National TV advertising breaks June 5 for first OTC liquid H2 antagonist. SmithKline Beecham's Tagamet HB extension launched in April (1"The Tan Sheet" May 15, p. 4). FSIs with a $2-off coupon for any size liquid and a $1 coupon for 12-count tablets will continue to be distributed throughout the year, accompanied by in-store promotions and $5 rebate coupons available with product on retail shelves, SB says. Product employs an accordion-style label in order to fit all necessary instructions and warnings (2"The Tan Sheet" July 19, 1999, p. 5)

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