Adasuve Approval History 
- FDA approved: Yes (First approved December 21st, 2012)
- Brand name: Adasuve
- Generic name: loxapine
- Previous name: AZ-004
- Company: Alexza Pharmaceuticals, Inc.
- Treatment for: Agitation, Schizophrenia, Bipolar Disorder
Adasuve (loxapine) is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
FDA Approval History for Adasuve
| Date | Article |
|---|
| Dec 21, 2012 |  FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults |
| Jul 6, 2012 | Alexza Announces Adasuve (Staccato Loxapine) PDUFA Goal Date of December 21, 2012 |
| May 3, 2012 | Alexza Receives Complete Response Letter for Adasuve NDA |
| Jan 23, 2012 | Alexza Announces Extension of the Adasuve PDUFA Goal Date by Three Months |
| Nov 6, 2011 | Alexza Announces the Adasuve (Staccato Loxapine) PDAC Meeting Date of December 12, 2011 |
| Aug 19, 2011 | Alexza Announces Adasuve Staccato (Loxapine) PDUFA Goal Date of February 4, 2012 |
| Aug 5, 2011 | Alexza Announces Resubmission of AZ-004 (Staccato Loxapine) NDA |
| Jan 18, 2011 | Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato Loxapine) NDA |
| Dec 7, 2010 | Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato Loxapine) |
| Oct 11, 2010 | Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato Loxapine) NDA |
| Feb 18, 2010 | Alexza Announces AZ-004 (Staccato Loxapine) PDUFA Goal Date of October 11, 2010 |
| Feb 10, 2010 | Biovail Enters into License and Collaboration Agreement with Alexza for AZ-004 |
| Dec 15, 2009 | Alexza Announces Submission of AZ-004 (Staccato Loxapine) NDA |
See also...
Adasuve (loxapine) Consumer Information
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