According to Alexza Pharmaceuticals, it plans to resubmit its NDA for AZ-004 (Staccato loxapine) for the treatment of agitation in schizophrenic patients in July 2011. The company received a complete response letter (CRL) for the product from the FDA in October 2010. The FDA CRL cited safety concerns due to decreases in FEV1 after inhalation of a dose. Read the company’s press release.
Alexza says it will resubmit AZ-004 NDA in July 2011
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