Priligy® - Dapoxetine

Here are some note worthy news pieces showing the
general development of Priligy® / Dapoxetine.
It is not our intention to follow every single news story
that ever mentions this drug, but rather give an indication
of a time line from its early beginnings of what has
happened with Priligy® / Dapoxetine to what is happening
today with its development. Please note these news
pieces are pharaphrased and maybe brief in content in
order to provide a quick overview.




July 11th, 2007
Johnson & Johnson is getting ready to file dapoxetine in Europe and Canada later this year for a treatement for premature ejaculation. This selective serotonin uptake inhibitor has shown excellent promise in being the first medication to treat PE. It has also not dismissed submitting it again to the FDA for approval in the US.

December 10th, 2007
Janssen-Cilag (a part of Johnson & Johnson) has submitted a Marketing Authorisation Application (MAA) for dapoxetine for the treatment of PE in men between the ages of 18 to 64. Sweden will act as the Reference Member State. Finland, Italy, Austria, Germany, Spain and Portugal will act as Concerned Member States regarding the application. It is there intention to have regulatory submissions take place in other parts of the world soon.

February 10th, 2009
Priligy™ (generic Dapoxetine) receives approval for Premature Ejaculation in Sweden and Finland. Janssen-Cilag  (a division of Janssen Pharmaceutica N. V.), announced that Priligy™ (dapoxetine) has received marketing authorisation in Finland and Sweden for the on-demand treatment of premature ejaculation (PE) in men 18-64 years of age. This comes as a result of positive outcome of seven European Union countries consisting of Austria, Germany, Spain, Portugal, Italy, Sweden and Finland. Sweden and Finland are the first nations to allow dapoxetine as a prescription treatment for premature ejaculation. It is expected that the other five countries mentioned will soon allow licenses for this treatment. At this time it is not approved for marketing in the US.

February 17th, 2009
Janssen-Ortho Inc, filed an application with Health Canada to market Priligy in Canada.

June 4th, 2009
Priligy is now available in Germany. J&J also seeks to sell the pill in Australia, Mexico, Turkey and six other countries

October 10th, 2009
Janssen Korea has been given the go ahead to start selling Priligy. This marks the first approval of Priligy in Asia.
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Priligy® / Dapoxetine Information