Sun Pharmaceutical Industries Ltd. announced that US FDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Uroxatral ER, alfuzosin hydrochloride extended release tablets.
Sun Pharma, being the first-to file an ANDA for generic Uroxatral ER with a para IV certification, received a 180 day marketing exclusivity.
These alfuzosin hydrochloride 10 mg tablets are therapeutically equivalent to Uroxatal Extended Release tablets from sanofi-aventis. Alfuzosin hydrochloride extended release tablets have annual sales of approximately USD 250 in the US.
Alfuzosin is an alpha 1 blocker for the treatment of signs and symptoms of benign prostatic hyperplasia.
Uroxatral is a registered trademark of sanofi-aventis U.S. LLC.