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Gynecology & Urology Approvals

Sun receives tentative FDA approval for generic alfuzosin

This article was originally published in Scrip

Executive Summary

Sun Pharmaceutical Industries has received tentative US FDA approval for its ANDA for alfuzosin hydrochloride 10mg tablets, a generic version of Sanofi Aventis's Uroxatral extended-release tablets. Alfuzosin is an alpha 1 blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia. Sales of alfuzosin hydrochloride tablets are estimated at about $180 million annually in the US.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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