Split Panel Recommends Adasuve With Changes to REMS, Dosing

Drug Industry Daily
A closely divided FDA advisory panel has recommended that the agency approve Alexza Pharmaceuticals' NDA for Adasuve to treat agitation in adults with schizophrenia or bipolar disorder, but approval should be based on a much lower dose than recommended by the sponsor and a much stricter risk evaluation and mitigation strategy (REMS).

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