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FDA delays Alexza’s inhaled antipsychotic on 'major’ NDA amendment

This article was originally published in Scrip

Executive Summary

The US FDA declared Alexza Pharmaceuticals' update to its proposed risk evaluation and mitigation strategy (REMS) plan a major amendment to the firm's new drug application (NDA) for Adasuve (loxapine), an inhaled antipsychotic under investigation to treat agitation associated with schizophrenia or bipolar disorder in adults – resulting in the agency’s decision on the NDA being delayed by three months.



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