Tuesday, January 13, 2015

Very Interesting: UPDATED: FDA stops import of Lilly's Cialis from Australia but Lilly says it doesn't make it there Erectile dysfunction drug coming from Australia plant contained both sildenafil and tadalafil January 12, 2015 | By Eric Palmer

The FDA Monday issued an import alert, saying it was banning Eli Lilly's Cialis made at a plant inAustralia 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.

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