Xatral OD filed for US marketing approval

French drugmaker Sanofi-Synthelabo has applied for marketing approval inthe USA for Xatral OD (alfuzosin 10mg), a sustained-release once-daily formulation of the alpha blocker developed using drug delivery technology supplied by SkyePharma of the UK (Marketletter January 22). Xatral OD is indicated for the treatment of symptoms in men with benign prostatic hyperplasia.

Although the immediate-release formulation of Xatral is already marketed in 80 countries around the world for BPH, the once-daily version will represent the product's first entrance into the US market. Xatral OD was introduced in Europe last year and is now available in six European countries and French overseas territories. In these countries, the sustained-release formulation has already gained a significant proportion of Xatral's sales, according to SkyePharma.