FDA Delays Decision on Alexza Antipsychotic Treatment

Law360, New York (January 23, 2012, 6:47 PM EST) -- The U.S. Food and Drug Administration moved its decision date back by three months on Alexza Pharmaceuticals Inc.'s schizophrenia drug delivery system, citing the company's recent update to its new drug application, Alexza announced Monday.

The Mountain View, Calif.-based company had submitted a new Risk Evaluation and Mitigation Strategy program for its Adasuve treatment to the FDA on Jan. 10, which the agency considered a major amendment to the NDA, worthy of an extra three months to review the application, Alexza said in a statement....
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