Sun Pharma gets US FDA nod to market generic Uroxatral tablets

20 Jul 2011 Evaluate

Sun Pharmaceutical Industries Ltd has received the US health regulator’s nod to market Alfuzosin Hydrochloride tablets, used in the treatment of prostatic hyperplasia, in the American market. Sun Pharma, being the first-to-file an abbreviated new drug application (ANDA) for generic Uroxatral ER with a para IV certification, received 180-day marketing exclusivity. Alfuzosin Hydrochloride extended release tablets, which are indicated for the treatment of signs and symptoms of benign prostatic hyperplasia, have annual sales of nearly $250 million in the US.crackcrack

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