Posted by Michael Wonder on 04 Sep 2018
Janssen submits esketamine nasal spray new drug application to U.S. FDA for treatment-resistant depression
4 September 2018 - Janssen today announced the submission of a new drug application to the U.S. FDA for esketamine nasal spray.
Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults.
The application is based on five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression: three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study.
