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20 Jul 2011

India's Sun Pharma Gets FDA Nod to Market Uroxatral Generic

Sun Pharmaceutical 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 Pharmaceutical Industries Ltd. said its subsidiary has received US FDA approval to market a generic version of Sanofi's Uroxatral tablets in the US.


Sun Pharma confirmed that its subsidiary has been given permission to market 10mg alfuzosin hydrochloride tablets, used to treat prostatic hyperplasia.  The Indian company has received 180-day marketing exclusivity of the drug.


Alfuzosin hydrochloride tablets have annual sales of approximately $250m in the US, and Sun Pharma has claimed that its version is therapeutically equivalent to Sanofi's Uroxatral.



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