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
|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|
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