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FDAnews Drug Daily Bulletin
Salix Gets FDA Warning for Metozolv Advertising
April 9, 2010
Salix Pharmaceuticals has received an FDA warning letter
promotional materials for its Metozolv orally disintegrating tablets (ODT) that omit risk information and suggest the drug is safer and more effective
than evidence has demonstrated. One promotional piece for the drug entirely omits risk information, according to a March 19 letter from the Division of
Drug Marketing, Advertising and Communications. Yet Metozolv ODT’s (metoclopramide HCl) prescribing information contains a boxed warning about tardive
dyskinesia, a movement disorder.
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