Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT, May 26 (DDMAC). (CFSAN AND DDMAC PROMO UNTITLED LETTERS).DDMAC DDMAC Division of Drug Marketing, Advertising and Communications objected to a promotional piece for Spiriva Handihaler (tiotropium bromide inhalation powder) in that the four-page promotional piece was misleading because it failed to reveal materials facts about the product. The promotional piece also was found to be misbranded mis·brand tr.v. mis·brand·ed, mis·brand·ing, mis·brands To brand or label misleadingly or fraudulently. Adj. 1. in that it contained the statement: "Attention: Atrovent (ipratropium bromide) inhalation aerosol (CFC CFC See: Controlled foreign corporation formulation) MDI (1) (Multiple Document Interface) A Windows function that allows an application to display and lets the user work with more than one document at the same time. is being discontinued ... now is the time to consider stepping up to the Sustained efficacy of spiriva," but it failed to reveal that Atrovent remains commercially available in a hydrofluoroalkane-134a (HFA) formulation. F-B; Doc. 13784W |
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