AZ-004 is indicated as a treatment of agitation in patients with schizophrenia or bipolar disorder.
In the original CRL, the Center for Drug Evaluation and Research of FDA rejected the NDA and asked the company to provide additional data in support of the application.
The refiling of the NDA consists of original data plus new data from a human factors study, stability data from new production batches manufactured late last year, updated manufacturing and controls sections addressing findings from the company’s Pre-Approval Inspection, and updated draft labeling and a comprehensive REMS proposal.