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    Skip Navigation LinksHome General News Sun Pharma announces USFDA tentative approval for generic Uroxatral Extended Release ® tablets
Sun Pharma announces USFDA tentative approval for generic Uroxatral Extended Release ® tablets

Sun Pharmaceutical Industries Ltd announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) for generic Uroxatral Extended Release ® tablets. These alfuzosin hydrochloride 10 mg tablets are therapeutically equivalent to Uroxatral Extended Release® tablets from Sanofi-Aventis. Alfuzosin hydrochloride tablets have annual sales of approximately USD 180 million in the US. Alfuzosin is an alpha 1 blocker for the treatment of the signs and symptoms of BPH.

Source: Sun Pharmaceuticals
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