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Company Name
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Alexza Pharmaceuticals Inc.
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Drug Name
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ADASUVE (NDA resubmission)
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Event Name
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FDA decision on ADASUVE for proposed treatment of agitation associated with schizophrenia or bipolar I disorder in adults
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Event Date
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12/21/2012
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Outcome
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FDA approves ADASUVE for treatment of agitation associated with schizophrenia or bipolar I disorder in adults
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Drug Status
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In May of 2012, FDA refused to approve ADASUVE due to manufacturing deficiencies at the company's Mountain View, California facility. The compay resbmitted the ADASUVE NDA on June 22, 2012.
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Rival Drugs
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Market Potential
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Other Approvals
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News |
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Return to FDA Calendar
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