AstraZeneca Gets One of Five New Indications for Seroquel

摘要

The FDA's approval of AstraZeneca's Seroquel as an adjunct to lithium or divalproex for the maintenance treatment of patients with bipolar I disorder gives the company one of five potential U.S. approvals for new indications for the product. The Seroquel (quetiapine fumarate) approval is based on two multicenter, randomized, double-blind, placebo-controlled trials that included a 12-36 week stabilization phase followed by up to two years of randomized, double-blind treatment, according to the company. The primary endpoint was time to recurrence of a depressive, manic or mixed mood event.