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A batch of Cialis pills, purportedly made at a plant in Australia, was banned from entering the United States after the pills were found to contain the active ingredient for rival erectile-dysfunction drug Viagra.
The U.S. Food and Drug Administration said Monday that the combination would represent an unapproved new drug. It didn’t say what such a hybrid medication would do to the human body.
Also a mystery: Who made the medicine. The FDA said the tablets, which included Cialis’s active ingredient, tadalafil, and Viagra’s sildenafil, were from an Eli Lilly and Co. plant in the Sydney suburb of West Ryde. Yet the Indianapolis-based company said it doesn’t operate a manufacturing site in Australia, and any Cialis product claiming to be from that country is a fake.
"Lilly does not manufacture Cialis in Australia," the company said in a written statement. "In fact, Lilly does not currently operate a manufacturing site in Australia for any of its products. Thus, any Cialis product with packaging stating it is from Lilly in Australia is not genuine."
Erectile dysfunction drugs are among the most frequently counterfeited medications, and people shouldn’t take the knockoffs anyway because they can be toxic, the company said.
A spokesman for Pfizer Inc., which makes Viagra, didn’t immediately comment on the FDA’s action. FDA press officials didn’t immediately respond to requests for further information on the plant in Australia. Lilly’s Australia division is run from the same address the FDA put on the import alert, according to the company’s website.
Cialis generated an estimated $2.3 billion in sales for Lilly last year, according to data compiled by Bloomberg.
Lilly shares closed down 0.7 percent on Monday, to $69.42 each, but rose 1.3 percent Monday morning, to $70.35.
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