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Sun Pharmaceutical has announced that it has been granted US regulatory approval for its generic Uroxatral Extended Release tablets used for treating benign prostatic hyperplasiam (BPH) or enlarged prostate.
In a filing to the Bombay Stock Exchange, Sun Pharmaceutical said it has received US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for generic Uroxatral Extended Release tablets.
These alfuzosin hydrochloride tablets have similar healing powers to Uroxatral Extended Release tablets from Sanofi-Aventis, the filing added.
Alfuzosin is an alpha one blocker for the treatment of the signs and symptoms of BHP, it added.
Copyright Press Association 2009