Risperdal, Zyprexa “approvable’ for teen schizophrenia
Executive Summary
FDA issues an "approvable" letter June 21 to Johnson & Johnson unit Janssen for Risperdal (risperidone) to treat schizophrenia in children ages 13-17. A potential competitor in the space, Lilly's Zyprexa (olanzapine), is also approvable for an identical indication. Lilly told "The Pink Sheet" it received an approvable letter April 30 for Zyprexa to treat teen schizophrenia and acute mania associated with bipolar I disorder in children ages 10-17 years. FDA did not request any new clinical trials for either drug, according to the firms. The sNDAs for both drugs received "priority" review...