Alexza Pharmaceuticals

EMA objects to Alexza’s Adasuve MAA

Tuesday, February 14, 2012

Alexza Pharmaceuticals has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve, which seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.

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FDA accepts Alexza’s Adasuve NDA

Friday, August 19, 2011

The FDA has accepted Alexza Pharmaceuticals’ ADASUVE New Drug Application (NDA) as a complete, class II response to the FDA’s action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.

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