Tadalafil has been studied in over 100 clinical pharmacology studies and clinical trials involving over 12,000 patients. More than 10,000 additional patients are currently involved in on-going studies. Almost 3 million men are estimated to have taken tadalafil since it was first approved in 2002 in the European Union. Tadalafil is now approved in 90 countries with submission approvals pending in the remaining countries where the drug will ultimately be commercially available.
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