FDA Advisory Panel Recommends Approval Of Esketamine Nasal Spray For TRD

On February 12, 2019, Janssen announced that the Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended approval of Janssen's SPRAVATO™ (esketamine) self-administered nasal spray for treatment-resistant depression (TRD) in adults. The FDA will consider the committee recommendation in making its final decision on Janssen's New Drug Application (NDA) that was submitted on September 4, 2018.  While the FDA is not bound by the committee's recommendation, it does take its advice into consideration. The FDA's decision is expected by March 4 . . .