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Home Industry News Recordati submits file for drug approval

Recordati submits file for drug approval

28th November 2008

Recordati has said it has submitted a marketing approval authorisation request for silodosin.

The submission to the European Medicines Agency follows the centralised endorsement procedure within the British Medicines and Healthcare products Regulatory Agency and the Italian Agenzia Italiana del Farmaco.

It is hoped approvals will be in the first half of 2010, with the product launch planned by the end of the same year, or the start of 2011.

Used as a treatment for the signs and symptoms of benignprostatic hyperplasia (BPH), silodosin is a powerful antagonist of the adrenergic receptors.

The condition is characterised by urination difficulties – such as nocturia, increased frequency and a sense of urgency or a weak stream – and is the most frequent reason for patients’ visits to a urologist.

Giovanni Recordati, chairman and chief executive officer of the company, said: “Recordati has been conducting original innovative research in the area of urology for a long time and has matured specific know-how.”

“The introduction of silodosin among our future new corporate products will allow Recordati to consolidate its presence.”

Established in 1926, the company is listed on the Italian Stock Exchange and has headquarters in Milan.

Recordati has a total staff of over 2,400.

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