Lilly, ICOS remove impotence drug info from Web
WASHINGTON, Jan 14 (Reuters) - Eli Lilly and Co. (NYSE:LLY - news) and ICOS Corp. (NasdaqNM:ICOS - news) have removed promotions for their experimental impotence treatment Cialis from Web sites after complaints from regulators, an ICOS spokeswoman said Monday.
The U.S. Food and Drug Administration sent a letter to Lilly ICOS, the companies' joint venture, charging that information about Cialis violated federal regulations that prohibit promotion of experimental drugs as safe and effective.
The companies have removed press releases with the information that drew objections from the Web sites while they discuss the matter with the FDA, ICOS spokeswoman Lacy Fitzpatrick said.
``We complied with the FDA request and removed the items containing promotional claims, pending resolution of the matter,'' Fitzpatrick said. ``We will cooperate with the FDA to resolve the issue.''
Lilly ICOS applied for FDA approval of Cialis, a possible rival to Pfizer Inc.'s (NYSE:PFE - news) blockbuster Viagra, last June, and the agency is reviewing the application.
The FDA's division of drug marketing, advertising and communications objected to claims on three Web sites, including statements that Cialis ``has the potential to be a valuable treatment for a large number of men'' and permits couples to ``regain spontaneity in their sexual relationship'' because it gives a 24-hour window to begin sex.
The agency also took issue with statements that dosing ``should be simple and uncomplicated'' and that the drug relaxes blood vessels, ``allowing increased blood flow to tissues.''
The FDA's letter was posted on its Web site on Monday. |
