US drug firm Alexza Pharmaceuticals (Nasdaq: ALXA) says that the US Food and Drug Administration will require additional time to complete its review of the New Drug Application for its antipsychotic drug candidate Adasuve (Staccato loxapine).
The news follows a positive advisory committee recommendation for the drug, albeit with a narrow vote of nine to eight, with one abstention (The Pharma Letter December 15, 2011). In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for the Adasuve has been extended from February 4, 2012 to May 4, 2012.
REMS program viewed as major amendment
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