SkyePharma/Sanofi UroXatral "approvable"
Executive Summary
Sanofi-Synthelabo and SkyePharma expect to launch UroXatral (once-daily alfuzosin) in 2002, Sanofi says following Oct. 5 "approvable" letter from FDA. European version of benign prostatic hyperplasia treatment was approved in January as Xatral OD
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Sanofi UroXatral Approval For BPH Includes Phase IV QT Study Commitment
Sanofi-Synthelabo's UroXatral Phase IV study will examine potential QT prolongation of alfuzosin in combination with a phosphodiesterase inhibitor erectile dysfunction agent following June 12 approval of the drug
Sanofi UroXatral Approval For BPH Includes Phase IV QT Study Commitment
Sanofi-Synthelabo's UroXatral Phase IV study will examine potential QT prolongation of alfuzosin in combination with a phosphodiesterase inhibitor erectile dysfunction agent following June 12 approval of the drug
UroXatral launch
Sanofi expects to launch UroXatral (once-daily alfuzosin) for benign prostatic hyperplasia treatment in 2003; Sanofi and SkyePharma received an "approvable" letter from FDA in October 2001 (1"The Pink Sheet" Oct. 15, 2001, In Brief)...