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In March 1999, the FDA issued GSK a warning letter for distributing promotional materials that present Zofran in a manner that is false or misleading because it lacks fair balance. The agencys Division of Drug Marketing, Advertising and Communications (DDMAC) concluded promotional material for Zofran violated the Federal Food, Drug and Cosmetic Act because it fails to present any information relating to the side risks associated with the drug. The agency ordered GSK to immediately cease distribution of Zofran promotional material that lacks risk information

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