In Brief: TAP Prevacid
Executive Summary
TAP Prevacid: Maintenance of healed duodenal ulcer indication approved April 17. Labeling adds that "controlled studies do not extend beyond 12 months." The efficacy of the recommended dose of 15 mg Prevacid (lanzoprazole) once daily in maintenance of endoscopic remission ranged from 70% to 84% compared to zero and 39% for placebo, respectively, at 12 months. Prevacid was previously indicated for short-term treatment. The sNDA (20-406/S-010) was submitted on April 24, 1996...