Vivus Muse Ad Omits Route Of Administration, FDA Warning Letter Says
A television advertisement for Vivus' erectile dysfunction urethral suppository Muse (alprostadil) fails to disclose the route of administration, an FDA warning letter says
You may also be interested in...
The pharmaceutical industry will come under increased scrutiny for direct-to-consumer advertising of Rx drugs as a drug benefit is added to Medicare, Senate Special Committee on Aging Chairman Larry Craig (R-Idaho) suggested
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 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.