Updated Feb 1, 2009 at 2:52 EST.
Dapoxetine ( Priligy TM ) was submitted for marketing authorization in several countries in
Europe in late 2007. Based on PPD expectations as published earlier this month,
PPD is “hoping for approval of the marketing authorisation application for dapoxetine in
Europe in the first quarter of this year”.
Sweden has been chosen by PPD and Johnson & Johnson as the leading country to review the dapoxetine file and therefore it is expected to be the first country to approve it.
In 2007 the pharmaceutical business review reported that Janssen-Cilag companies in
Europe ( a Johnson & Johnson company ) have submitted a marketing authorization application ( MAA ) for dapoxetine seeking the indication as a treatment for premature ejaculation ( PE ).
The marketing authorization application for ( Priligy TM ) was submitted under a decentralized procedure, in which
Sweden has been chosen as the reference member state. In addition,
Austria,
Finland,
Germany,
Italy,
Portugal and
Spain will be the additional EU member states for the application. It is expected that if approved in
Europe, regulatory submissions in other regions of the world will follow.
By the PEhomepage editorial team
Written by the PEhomepage.com Editorial Team.
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