The European Commission yesterday (June 26) has granted marketing authorization for USA-based Vivus’ (Nasdaq: VVUS) Spedra (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The drug was approved by the US Food and Drug Administration last year, under the trade name Stendra (The Pharma Letter April 30, 2013).
The approval of the marketing authorization application by the EC follows the positive recommendation by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in April 2013. Spedra, a PDE5 inhibitor, is the first new chemical entity (NCE) approved for ED in over a decade, the company noted.
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