Seroquel XR quetiapine fumarate regulatory update

FDA approved an sNDA from AstraZeneca for once-daily Seroquel XR quetiapine as an adjunct to antidepressants to treat major depressive disorder (MDD) in adults. However, the company received a complete response letter from FDA for a pair of sNDAs for Seroquel XR as monotherapy for acute and maintenance treatment of MDD in adults. AstraZeneca did not disclose the contents of the letter. In April, FDA's Psychopharmacologic Drugs Advisory Committee supported use of Seroquel XR in combination with other drugs to treat MDD, but was split on whether to recommend use of the drug as monotherapy (see BioCentury, April 13). The extended-release formulation of dibenzothiazepine, an atypical antipsychotic, is approved in the U.S. to treat schizophrenia in patients aged 13 and up, and bipolar disorder in patients aged 10 and up. ...