Alexza Pharma receives complete response letter for Adasuve NDA

theflyonthewall.com

Alexza Pharmaceuticals announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for ADASUVE 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. In the CRL, 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." Alexza believes the deficiencies are medical device specific and readily addressable. Alexza plans to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical.

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