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news.Italy-based pharmaceutical company Recordati has submitted a marketing approval authorization request for silodosin, a new compound indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, to the European Medicines Agency.
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This marketing approval authorization (MAA) submission will follow the centralized approval procedure with the British Medicines and Healthcare products Regulatory Agency acting as rapporteur and the Italian Agenzia Italiana del Farmaco as co-rapporteur. Approval is expected in the first half 2010 and the product launch could take place by end 2010 or beginning 2011.
Worldwide development of silodosin was conducted jointly by Watson Pharmaceuticals in North America, by Recordati for its territories, and by Kissei Pharmaceutical for the rest of the world.
Giovanni Recordati, chairman and CEO of Recordati, said: “The introduction of silodosin among our future new corporate products will allow Recordati to consolidate its presence in the therapeutic area of urology, an area within which it has been present for many years with flavoxate, the first Italian active ingredient to be approved by the FDA in the US, and more recently with Kentera, a drug indicated for the treatment of urinary incontinence.”