Alexza Pharmaceuticals on Monday announced that that it received a complete response letter from the FDA regarding its application for AZ-004 for the rapid treatment of agitation in schizophrenia or bipolar disorder patients. In the letter, the agency stated that the application is not ready for approval in its present form due to safety concerns.
Reference Articles
Alexza Pharmaceuticals receives Complete Response Letter for AZ-004 (Staccato loxapine) NDA - (Alexza)
Alexza say FDA declines inhaled agitation drug - (CNBC)
Alexza shares sink as the FDA denies its antipsychotic drug - (Daily Finance)
Alexza plunges on FDA setback; drug indexes flat - (MarketWatch)
Alexza to meet with FDA to address concerns on bipolar drug - (The Wall Street Journal)
Alexza Pharm: FDA doesn't approve AZ-004 - (TheStreet.com)
**Published in "First Word"
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