JNJ – Johnson & Johnson PDUFA for Esketamine, Treatment resistant depression is expected by March 3-4, 2019.
FDA Advisory Committee Meeting February 12, 2019. Meeting notes likely out February 8, 2019.
The committees will discuss efficacy, safety and risk-benefit profile of new drug application (NDA) 211243, esketamine 28 mg single-use nasal spray device, submitted by Janssen Pharmaceuticals, Inc., for the treatment of treatment-resistant depression. FDA intends to make background material available to the public no later than two (2) business days before the meeting.