FDAnews Drug Daily Bulletin

A “tent card” Sanofi-Aventis prepared to promote Uroxatral to treat benign prostatic hyperplasia presents overblown efficacy claims and should be withdrawn, according to an FDA untitled letter. The agency’s Division of Drug Marketing, Advertising and Communications says the promotional materials for Uroxatral (alfuzosin HCl) extended-release tablets presented efficacy claims for the drug without stating its indication or giving risk information. The company is evaluating the letter to determine appropriate next steps, spokeswoman Susan Brooks said.
Washington Drug Letter