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Home Industry News Almirall receives positive recommendation for silodosin from EMEA

Almirall receives positive recommendation for silodosin from EMEA

27th November 2009

Almirall has announced that the European Medicines Agency (EMEA) has given a positive opinion for silodosin, recommending a marketing authorisation for both Urorec and Silodyx.

This applies to doses of 4 mg, 8 mg and hard capsules of the drug – which is intended for the treatment of the symptoms of benign prostatic hyperplasia (BPH).

The EMEA’s final decision on the matter is anticipated to be issued within 67 days from the original recommendation.

Almirall received the rights to market the product from fellow pharmaceutical firm Recordati, which, in turn, bought the EU rights from the drug’s original developer, Kissei Pharmaceutical.

Silodosin blocks receptors, causing smooth muscles in the prostrate, urinary bladder base and prostatic urethra to relax, thereby decreasing the bladder outlet resistance brought about by BPH.

In other recent Almirall news, the firm posted its financial results for the third quarter of 2009 – reporting a rise in net sales of 2.4 per cent during the period.

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