Johnson & Johnson: submits depression nasal spray to FDA
(CercleFinance.com) - J&J's Janssen has submited a new drug application on a nasal spray that could become the first new mechanism of action in 30 years for treating the mental illness to the US FDA.
Janssen today announced the submission of a new drug application to the Food and Drug Administration, seeking approval of esketamine for treatment-resistant depression in adults.
Janssen plans to submit a marketing authorisation application to the European Medicines Agency later in 2018.
The drugmaker is currently conducting Phase 3 clinical studies for a second indication, major depressive disorder with imminent risk of suicide.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
Janssen today announced the submission of a new drug application to the Food and Drug Administration, seeking approval of esketamine for treatment-resistant depression in adults.
Janssen plans to submit a marketing authorisation application to the European Medicines Agency later in 2018.
The drugmaker is currently conducting Phase 3 clinical studies for a second indication, major depressive disorder with imminent risk of suicide.
Copyright (c) 2018 CercleFinance.com. All rights reserved.