FDA Issues Complete Response Letter to NDA for Adasuve
Alexza Pharmaceuticals announced that it has received a complete response letter from the FDA regarding its New Drug Application (NDA) for Adasuve (Staccato loxapine) inhalation powder, 5mg and 10mg, for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
In the complete response letter, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility. Satisfactory resolution of these deficiencies is required before this application may be approved."
Adasuve is an anti-agitation product that combines loxapine, an antipsychotic, with Alexza's Staccato system that vaporizes the drug into small particle aerosol for inhalation, which allows for rapid onset of action.
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