Adasuve FDA Approval History
FDA Approved: Yes (First approved December 21, 2012)
Brand name: Adasuve
Generic name: loxapine
Dosage form: Inhalation Powder
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.
Development timeline for Adasuve
Date | Article |
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Dec 21, 2012 | Approval 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 |
Further information
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