Alexza's Manufacturing Issues Delay FDA Approval Of Adasuve

Law360, Washington (May 4, 2012, 3:00 PM EDT) -- Alexza Pharmaceuticals Inc.'s antipsychotic drug delivery system hit another snag Thursday when the U.S. Food and Drug Administration told the company it couldn't approve the device until the company resolved unspecified manufacturing issues.

According to the company, an FDA field investigator found deficiencies at its Mountain View, Calif., manufacturing plant that again push back Alexza's shot at FDA approval for Adasuve, a schizophrenia and bipolar disorder treatment. FDA also informed the company in its complete response letter that it can continue to discuss the new Risk...
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