Alexza Pharmaceuticals

EMA objects to Alexza’s Adasuve MAA

Tuesday, February 14, 2012 07:18 AM

Alexza Pharmaceuticals has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve, which seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.

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Alexza extends Adasuve PDUFA goal date by three months

Monday, January 23, 2012 12:56 PM

The FDA will require additional time to complete its review of the New Drug Application (NDA) for Adasuve (Staccato loxapine), according to Alexza Pharmaceuticals.

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Alexza retains Lazard, reduces workforce

Monday, December 19, 2011 01:53 PM

Alexza Pharmaceuticals has retained Lazard to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions.

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FDA accepts Alexza’s Adasuve NDA

Friday, August 19, 2011 10:33 AM

The FDA has accepted Alexza Pharmaceuticals’ ADASUVE New Drug Application (NDA) as a complete, class II response to the FDA's action letter, with an indicated Prescription Drug User Fee Act (PDUFA) goal date of February 4, 2012.  Alexza resubmitted the ADASUVE NDA, which seeks marketing approval for the rapid treatment of agitation in adults with schizophrenia or bipolar disorder.

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