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Sun Pharma announces USFDA approval for generic Uroxatral ER tablets
Sun Pharma announces USFDA approval for generic Uroxatral ER tablets Sun Pharmaceutical Industries has announced that USFDA 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 US$ 250 million in the US. Alfuzosin is an alpha 1 blocker for the treatment of signs and symptoms of benign prostatic hyperplasia. The company made this announcement during the trading hours today, 19 July 2011.

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