The European Commission approved Eli Lilly’s Cialis 5 mg (tadalafil) for treating the signs and symptoms of benign prostatic hyperplasia (BPH). EU clearance adds a new indication for the drug in Europe, where Cialis has been approved since 2002 in various dose strengths as an on-demand treatment for erectile dysfunction (ED). Once-daily Cialis was approved for the ED indication in 2007.

FDA approved Cialis 5 mg for the BPH indication a year ago, and also sanctioned Cialis 5 mg for once-daily in men who have both erectile dysfunction and signs and symptoms of benign prostatic hyperplasia.

Cialis is Lilly’s fourth top-selling human drug, which made global sales of $482.1 million in the third quarter of 2012, up 3% on Q3 2011 sales. U.S. sales of Cialis were $205.7 million (up 22%) during Q3 2012, driven by higher prices and increased demand. Sales of Cialis outside the U.S. were, conversely, down 8% at $276.4 million, due to the unfavorable impact of foreign exchange rates. Global sales of Cialis for the year to date reached $1.4 billion, up about 2% the equivalent period in 2011. 

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