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Sanofi-Synthélabo Receives FDA Approvable Letter for Uroxatral®
France, October, 2001 --- French drugmaker Sanofi-Synthélabo
announced that it has received from the US
Food and Drug Administration (FDA) an approvable letter for UroXatral®
(once-daily formulation of alfuzosin) for the treatment of men with symptomatic
benign prostatic hyperplasia (BPH).
The New Drug Application for UroXatral® was submitted in December 2000 in the United States. The once-daily formulation has been approved in Europe for several years, and it is currently marketed in 10 countries in Europe and in 25 other countries.
Alfusozin is an alpha-blocking agent, in the same class as Hytrin (terazosin) and Cardura (doxazosin), both of which are now generically available, but require daily multi-dosing. UroXatral will join FloMax (tamsulosin) as an alternative once-a-day alpha blocker.
Complete product information about alfusozin (UroXatral) usage in Europe is available online.
USRF has been involved in alfusozin clinical trials for the past 3 years.
In a huge study from France, alfuzosin outcomes in more than 7,000 men were reported, and remarkably, no retrograde ejaculation was seen. If preservation of ejaculation is confirmed in men taking alfuzosin, this may constitute a distinct advantage of this new product over the competition.