Navigation Links
Alexza Announces AZ-004 (Staccato(R) Loxapine) PDUFA Goal Date of October 11, 2010
Date:2/11/2010

MOUNTAIN VIEW, Calif., Feb. 11 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food & Drug Administration has accepted the AZ-004 NDA for filing and has indicated a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010.  Alexza filed the AZ-004 NDA on December 11, 2009 and is seeking marketing approval for the rapid treatment of agitation in patients with schizophrenia or bipolar disorder.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions.  Alexza's technology, the Staccato system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation.  The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

AZ-004 (Staccato loxapine) is Alexza's lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients.  Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials.  In February 2010, Alexza established a collaboration with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation ( BVF), to develop and commercialize AZ-004 in the U.S. and Canada.

Alexza has
'/>"/>

SOURCE Alexza Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Alexza Announces Submission of AZ-004 (Staccato(R) Loxapine) NDA
2. Alexza Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
3. Alexza to Announce 2009 Third Quarter Financial Results and Update Its AZ-004 NDA Status on Monday, November 9, 2009
4. Alexza Pharmaceuticals to Present at the Fourth Annual JMP Securities Healthcare Focus Conference
5. Alexza Announces Preliminary Results from its AZ-104 (Staccato(R) Loxapine) Phase 2b Trial in Patients with Migraine Headache
6. Alexza Reports 2009 First Quarter Financial Results and Updates Clinical Pipeline Status
7. Endo Pharmaceuticals and Alexza Pharmaceuticals Conclude Research Collaboration
8. Alexza Initiates AZ-104 (Staccato(R) Loxapine) Phase 2b Clinical Trial in Patients With Migraine Headaches
9. Alexzas AZ-004 (Staccato(R) Loxapine) Meets Primary Endpoint of Treating Acute Agitation in Patients with Bipolar Disorder in Phase 3 Trial
10. Alexzas AZ-004 (Staccato(R) Loxapine) Phase 3 Trial Meets Primary Endpoint of Treating Acute Agitation in Schizophrenic Patients
11. Alexza Reports 2008 Second Quarter Financial Results and Updates Development of Product Candidates
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... 2, 2014  EMD Serono, Inc., a subsidiary of ... today that Drew Young has joined the ... this capacity, he will be responsible for leading the ... including future products.   Bringing more than 20 ... sales efforts at pharmaceutical and biotech companies, Mr. Young ...
(Date:9/2/2014)... 2014  Cyberonics, Inc. (NASDAQ: CYBX ... study.  Results of the study presented by a ... cardiology congress and concurrently published by the ... Therapy (ART) in patients with moderate to severe ... safe, improves the heart,s ability to pump blood, ...
(Date:9/2/2014)... , Sept. 2, 2014 ResMed (NYSE: ... 150 devices in the United States ... portable, lightweight, and user-friendly life support ventilators. ... mobility and ease of use for patients suffering from ... adult and childhood respiratory disorders. The U.S. launch comes ...
Breaking Medicine Technology:EMD Serono Appoints Drew Young to Senior Vice President, Neurology and Immunology 2EMD Serono Appoints Drew Young to Senior Vice President, Neurology and Immunology 3EMD Serono Appoints Drew Young to Senior Vice President, Neurology and Immunology 4ANTHEM-HF Shows Autonomic Regulation Therapy Is Safe And Improves Heart Function In Patients With Chronic Heart Failure 2ANTHEM-HF Shows Autonomic Regulation Therapy Is Safe And Improves Heart Function In Patients With Chronic Heart Failure 3ANTHEM-HF Shows Autonomic Regulation Therapy Is Safe And Improves Heart Function In Patients With Chronic Heart Failure 4ANTHEM-HF Shows Autonomic Regulation Therapy Is Safe And Improves Heart Function In Patients With Chronic Heart Failure 5ResMed's Revolutionary Life Support Ventilation Platform -- Astral 100 and 150 Devices Now Available in the U.S. 2ResMed's Revolutionary Life Support Ventilation Platform -- Astral 100 and 150 Devices Now Available in the U.S. 3
... YORK, Dec. 23, 2010 Dr. David Samadi, robotic ... of Urology, and Chief of Robotics and Minimally Invasive Surgery ... continues to break barriers by sharing his robotic surgery ... worldwide. Today, Samadi, a pioneer surgeon in the field of ...
... 23, 2010 Generex Biotechnology Corporation ( www.generex.com ) (OTC ... to extend the closing date of its previously announced acquisition ... www.globalmeddirect.com ) to June 1, 2011. The Company ... decision of the Nasdaq Listing and Hearing Review Council affirming ...
Cached Medicine Technology:Robotic Surgery Expert Dr. David Samadi, MD Travels to Israel to Perform a Live Robotic Prostatectomy 2Robotic Surgery Expert Dr. David Samadi, MD Travels to Israel to Perform a Live Robotic Prostatectomy 3Generex Announces Extension of Global Medical Direct Acquisition Closing Date 2Generex Announces Extension of Global Medical Direct Acquisition Closing Date 3
(Date:9/2/2014)... Boca Raton, FL (PRWEB) September 02, 2014 ... online audience targeting and multi-channel email marketing is pleased ... to the market, Firearms & Freedom as ... these online properties represent more than one million concerned ... and display advertising. , “We are honored to ...
(Date:9/2/2014)... patient adherence to treatment following a myocardial infarction ... results reported at the European Society of Cardiology,s ... Principal Investigator Valentin Fuster, MD, PhD, Director of ... at Mount Sinai and General Director of the ... in Madrid, Spain, the novel fixed-dose combination drug ...
(Date:9/2/2014)... of California, San Diego School of Medicine have identified ... The findings, reported in the current issue of ... cancer mortality worldwide. An estimated 40,000 women in America ... the American Cancer Society. , "The take-home message of ... to target breast cancer metastasis through a pathway regulated ...
(Date:9/2/2014)... associated with many health risks, including heart disease and ... possible way to mitigate one often-overlooked risk: not buckling ... by Sheldon H. Jacobson, a professor of computer science ... are associated with a decrease in seatbelt usage. However, ... in effect. , "Primary seatbelt laws lead to increased ...
(Date:9/2/2014)... 02, 2014 To commemorate the 13th ... children’s literacy organization that has donated more than 200,000 ... founding in 2001, will host the 5th Annual BJF ... p.m. at Barnes & Noble Tribeca. Featuring special guest ... public event for children and families will celebrate the ...
Breaking Medicine News(10 mins):Health News:ASG Continues to Bring New Lists to Market 2Health News:ASG Continues to Bring New Lists to Market 3Health News:New polypill increases heart attack patients' medication adherence 2Health News:New polypill increases heart attack patients' medication adherence 3Health News:Enzyme controlling metastasis of breast cancer identified 2Health News:Seatbelt laws encourage obese drivers to buckle up 2Health News:Brooke Jackman Foundation Hosts 5th Annual Read-A-Thon, A Celebration of Hope and Literacy in New York City to Commemorate 13th Anniversary of 9/11 2Health News:Brooke Jackman Foundation Hosts 5th Annual Read-A-Thon, A Celebration of Hope and Literacy in New York City to Commemorate 13th Anniversary of 9/11 3
... , TUESDAY, Sept. 27 (HealthDay News) -- Men may need ... suggests. The study found that men were far more ... adenomas) in their colon -- 24.9 percent of men compared ... at an earlier age. "In our study, analysis of ...
... Discussing and documenting patients, preferences for care at the end ... recent claims. A new study published today in the ... with their physicians about end-of-life care and have an advance ... patients who do not have these discussions and documents. ...
... Steven Reinberg HealthDay Reporter , TUESDAY, Sept. 27 ... to an enlarged prostate, saw palmetto extract doesn,t seem to ... at high doses, a new study finds. Many men ... relieve lower urinary tract symptoms related to benign prostatic hyperplasia ...
... been honored with the Presidential Early Career Award ... and scientific leadership. It is the highest honor ... engineering professionals in the early stages of their ... Sept. 26. Justin Kasper, an astrophysicist at ...
... TUESDAY, Sept. 27 (HealthDay News) -- Average annual premiums for ... past year, to more than $15,000, according to new research ... Educational Trust. On average, U.S. workers now pay more ... has far outpaced growth in workers, wages, the 2011 employer ...
... an associate professor in the department of mathematical ... Arts, has received the honor of "Excellence in ... Convocation at NJIT traditionally honors select faculty ... level of excellence over a sustained period. ...
Cached Medicine News:Health News:Do Men Need Colon Cancer Screening Earlier Than Women Do? 2Health News:Do Men Need Colon Cancer Screening Earlier Than Women Do? 3Health News:Saw Palmetto Doesn't Help Enlarged Prostate: Study 2Health News:Saw Palmetto Doesn't Help Enlarged Prostate: Study 3Health News:President Barack Obama recognizes outstanding scientists at the Smithsonian 2Health News:Cost of U.S. Workers' Health Premiums Surged in 2011 2Health News:Cost of U.S. Workers' Health Premiums Surged in 2011 3Health News:Gifted mathematician honored at NJIT convocation 2
... DXC-990 camera is a 3 chip 1/2 inch color ... and a high s/n ratio. It offers picture contrast ... and knee control. The user can choose automatic exposure ... The Sony DXC-990 camera is a bayonet mount and ...
Sony DSR-20MD is the right choice If you need digital recording capability. It accepts both s-video and composite inputs....
... image management. Mediscan is an advanced ... derived from extensive experience with clinicians. ... organize, and distribute high quality images, ... effort. Can be connected to flexible ...
For continuous intracranial monitoring of pressure, oxygen and temperature of the brain...
Medicine Products: