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Bayer Pharmaceuticals, West Haven, CT, April 13 (DDMAC).

DDMAC DDMAC Division of Drug Marketing, Advertising and Communications  reviewed Bayer's television advertisement for Levitra (vardenafil HCI (Human Computer Interaction) Refers to the design and implementation of computer systems that people interact with. It includes desktop systems as well as embedded systems in all kinds of devices. ) and found the ad made false and misleading claims regarding superiority, disclose the drug's indications or provide information regarding side effects and contraindications.

According to the FDA-approved PI, Levitra, which is marketed through Schering Corp. and G1axoSmithYline, is indicated for the treatment of erectile dysfunction (ED).

The ad to which the agency objected was called "My Man," and, according to FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
, made a misrepresentation indicating that Levitra is superior to other treatments for ED by claiming it is the "best way to experience the difference." F-B F-B Forward - Backward (radar image analysis) ; Doc. 13454W
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Title Annotation:CFSAN and DDMAC PROMO UNTITLED LETTERS
Publication:Warning Letter Bulletin
Date:May 1, 2005
Words:97
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