Reuters: Regulatory News: Alexza's agitation drug gets FDA approval

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Alexza's agitation drug gets FDA approval Dec 21st 2012, 21:00 Fri Dec 21, 2012 4:00pm EST Dec 21 (Reuters) - Alexza Pharmaceuticals Inc said the U.S. health regulators approved Adasuve, making it the first treatment for schizophrenia and bipolar disorder that can be inhaled. Adasuve, which delivers an older antipsychotic drug called loxapine, passes through the lungs and into the bloodstream faster than a typical pill. Loxapine is available as an oral drug for schizophrenia. Three injectable drugs, Bristol-Myers Squibb's Abilify, Eli Lilly's Zyprexa and Pfizer Inc's Geodon, are currently approved to calm patients with schizophrenia or bipolar disorder. Adasuve, Alexza's most advanced drug, will be available for commercial launch early in the third quarter of 2013, the company said. Earlier this month, European health regulators recommended approval of Adasuve. The FDA denied approval to Adasuve in May, after it found deficiencies at the company's Mountain View, California manufacturing facility during an inspection. Trading in the company's shares was halted at $5.79, down 7 percent, on the Nasdaq on Friday.

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