FDA grants tentative approval to Teva’s generic Uroxatral

ROCKVILLE, Md. The Food and Drug Administration has given tentative approval to Teva Pharmaceutical Industries' generic version of Sanofi-Aventis’ Uroxatral, FDA records show.

The agency granted the tentative approval to Teva’s alfuzosin hydrochloride extended-release tablets in the 10 mg strength. Alfuzosin hydrochloride is used to treat enlarged prostate.

Uroxatral is a once-daily version of Xatral, which had global sales of $439.2 million in 2007, according to Sanofi-Aventis financial records. Sanofi sued Teva and other generics companies in September 2007 when they sought FDA approval for generic versions of Uroxatral.