Approved (EU)

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The European Commission (EC) granted the marketing authorization for SPEDRA™ (avanafil) for the treatment of erectile dysfunction (ED) in the European Union (EU). The approval of the marketing authorization application (MAA) by the EC follows the positive recommendation by the European Medicines Agency's (EMA) 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.

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For information about VIVUS' Products approved in the US, click here