Sun Pharma Gets USFDA Approval to Market Generic Uroxatral ER Tablets in the US
Sun Pharmaceutical Industries Ltd has received US Food and Drug Administration (USFDA) nod to market generic version of Uroxatral (Alfuzosin Hydrochloride) tablets in the US. These are extended release tablets of 10mg strength.
Alfuzosin Hydrochloride extended release tablet is indicated in the treatment of signs and symptoms of enlarged prostate (benign prostatic hyperplasia, BPH). BPH is characterized by the enlargement of the prostate gland, the symptoms of which include urinary frequency and difficulty urinating. Alfuzosin Hydrochloride is an alpha adrenergic blocker that works by relaxing the muscles around the prostate gland. It helps relieve a range of urinary disorders. This medicine seems to be beneficial regardless of any age or prostate size.
Sun Pharma was the first to file an abbreviated new drug application (ANDA) for generic Uroxatral ER with a para IV certification and received a 180-day marketing exclusivity. Sun Pharma's Alfuzosin Hydrochloride tablets are equivalent to Sanofi-Aventis' Uroxatal extended release tablets.
July 25, 2011