Sun Pharma's US based subsidiary has received US FDA tentative approval for its ANDA for generic Uroxatral Extended Release tablets.
These alfuzosin hydrochloride 10 mg tablets are therapeutically equivalent to Uroxatral Extended Release tablets from sanofi-aventis. Alfuzosin hydrochloride tablets have annual sales of approximately USD 180 million in the US.
Alfuzosin is an alpha 1 blocker for the treatment of the signs and symptoms of BPH.