JNJ – Johnson & Johnson PDUFA for Esketamine

When:
February 8, 2019 – March 4, 2019 all-day
2019-02-08T00:00:00-05:00
2019-03-05T00:00:00-05:00

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.

Shutdown risks delaying FDA approval of potentially life-saving drugs and therapies

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