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Adasuve 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 History and FDA Approval Process for Adasuve

DateArticle
Dec 21, 2012Approval FDA Approves Adasuve (loxapine) Inhalation Powder for the Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I Disorder in Adults
Jul  6, 2012Alexza Announces Adasuve (Staccato Loxapine) PDUFA Goal Date of December 21, 2012
May  3, 2012Alexza Receives Complete Response Letter for Adasuve NDA
Jan 23, 2012Alexza Announces Extension of the Adasuve PDUFA Goal Date by Three Months
Nov  6, 2011Alexza Announces the Adasuve (Staccato Loxapine) PDAC Meeting Date of December 12, 2011
Aug 19, 2011Alexza Announces Adasuve Staccato (Loxapine) PDUFA Goal Date of February 4, 2012
Aug  5, 2011Alexza Announces Resubmission of AZ-004 (Staccato Loxapine) NDA
Jan 18, 2011Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato Loxapine) NDA
Dec  7, 2010Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato Loxapine)
Oct 11, 2010Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato Loxapine) NDA
Feb 18, 2010Alexza Announces AZ-004 (Staccato Loxapine) PDUFA Goal Date of October 11, 2010
Feb 10, 2010Biovail Enters into License and Collaboration Agreement with Alexza for AZ-004
Dec 15, 2009Alexza Announces Submission of AZ-004 (Staccato Loxapine) NDA

Further information

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