Alexza Receives Complete Response Letter for Adasuve NDA
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ADASUVE™ (loxapine) inhalation powder, 5 mg and 10 mg. The CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form. ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
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