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Vivus Muse Ad Omits Route Of Administration, FDA Warning Letter Says

Executive Summary

A television advertisement for Vivus' erectile dysfunction urethral suppository Muse (alprostadil) fails to disclose the route of administration, an FDA warning letter says

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Vivus Muse

Use of the term "urethral suppository" in a consumer print ad for the transurethral alprostadil erectile dysfunction therapy represents an "unfamiliar medical term," FDA maintains in April 1 letter to firm. "The majority of men exposed to this advertisement will not understand that Muse is a suppository designed to be inserted in the opening of a man's penis," FDA explains. Muse TV broadcast ads were the subject of a February NOV letter from FDA for inadequate information on side effects, including hypotension ("The Pink Sheet" March 9, p. 12)

Vivus Is Preparing Revised TV Ads For Muse Following FDA NOV Letter

Vivus is in discussions with FDA regarding revised TV broadcast ads for its erectile dysfunction therapy, Muse (alprostadil), following receipt of a notice of violation letter from the agency objecting to certain aspects of the company's TV and print ad campaigns.

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