FDA accepts AZ-004 NDA

FDA accepted for filing an NDA from Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) for Staccato loxapine ( AZ-004) to treat agitation in patients with schizophrenia or bipolar disorder. The PDUFA date is Oct. 11. AZ-004 is loxapine delivered by Alexza's Staccato system inhaler. On Wednesday, Alexza granted Biovail Corp. (TSX:BVF; NYSE:BVF) exclusive rights in the U.S. and Canada to develop and commercialize AZ-004 (See BioCentury Extra, Wednesday, Feb. 10, 2010). ...