UPDATED: FDA stops import of Lilly's Cialis from Australia but Lilly says it doesn't make it there

The FDA Monday issued an import alert, saying it was banning Eli Lilly's Cialis made at a plant in Australia because testing showed it contained not only the active pharmaceutical ingredient approved for Cialis but also the API that goes in Pfizer's competing erectile dysfunction drug Viagra. The problem, Lilly ($LLY) said in a statement, is that it doesn't currently have a plant in Australia, making Cialis or anything else.

The import alert posted by the FDA Monday said "sample analysis" of Cialis coming from the plant in West Ryde found that it not only contained tadalafil, but also sildenafil, which is the API in Viagra. "Although Cialis is currently an approved new drug product, the current application does not include the combination of tadalafil and sildenafil. As such; the aforementioned product appears to be an unapproved new drug," the FDA said in the alert.

But Lilly, in a statement emailed to FiercePharmaManufacturing on Monday, said the company had contacted the FDA to see what's up. "Lilly does not manufacture Cialis in Australia. 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," the company said. "This appears to be a counterfeit version of Cialis." The company pointed out that erectile dysfunction drugs are often counterfeited, citing statistics that 37% of seized counterfeits are ED drugs.

Lilly spokeswoman Celeste Stanley said Lilly quit manufacturing human drugs in Australia in 1985 and its animal health operation stopped making products there in 2008. "Lilly has never manufactured Cialis in Australia," she said. 

A spokesperson for Pfizer ($PFE) said it would be "improper for us to comment on another company's product."

Both companies continue to see blockbuster sales from their ED drugs, although Pfizer has seen a steady slide as Viagra has gone off patent in the U.K. and some Asian countries. For the 9 months ended September 30, Viagra turned in $1.23 billion in sales, down 12.6%, while the longer-lasting Cialis had revenues of $1.67 billion, up 6%.

- here's the import alert

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