FDA Requires Additional Data For Seroquel XR Supplemental New Drug Application

The U.S. FDA (Food and Drug Administration) has asked AstraZeneca, the makers of Seroquel XR (quetiapine fumarate), for additional information for its extended release tablets for the treatment of MDD (Major Depressive Disorder) in adult patients. The FDA’s CRL (Complete Response Letter) was sent to AstraZeneca on 24th December. AstraZeneca says it is evaluating the contents of the letter and the proposed labeling revisions.

More: continued here

Filed under: Depression on January 3rd, 2009