Bayer has received European approval for a new formulation of Levitra (vardenafil HCI)

Bayer claimed that Levitra 10mg orodispersible tablet is expected to be the first ED medication available in this new and convenient formulation.

Levitra 10mg orodispersible tablet is expected to allow men a discreet and convenient intake without water, dissolving on the tongue within seconds with a minty flavour.

Levitra 10mg orodispersible tablet has received approval based on the results from Phase III multinational trials Potent I and II which compared the efficacy and safety of 10mg vardenafil orodispersible tablet with placebo after 12 weeks of treatment in a general population of men with ED.

For both Potent I and Potent II studies, vardenafil orodispersible therapy was superior to placebo for all primary and secondary efficacy measures.

Bayer said that the introduction of Levitra in Europe is expected to be initiated in November 2010, while in US it has received approval in June 2010 and is expected to be marketed as Staxyn by GlaxoSmithKline and Merck.
(Source: http://regulatoryaffairs.pharmaceutical-business-review.com)