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:12/19/2014)... N.C. , Dec. 19, 2014 ... optimize a product,s web presence to reflect the ... websites, in particular, must meet the needs of ... and culture. According to recent ... than half of the participating companies averaged more ...
(Date:12/19/2014)... and CARDIFF-BY-THE-SEA, Calif. , ... SRNE ;  Sorrento), an oncology company ... and Conkwest, Inc., a privately-held immuno-oncology company developing ... (NK) cell-line based therapy, announced today that the ... jointly develop next generation CAR-TNK™ (pronounced as "Car-Tank") ...
(Date:12/19/2014)... Dec. 18, 2014 Research and Markets ... of the "Micro Market Monitor: North American ... offering. http://photos.prnewswire.com/prnh/20130307/600769 ... progressing steadily, which has resulted in fueling the ... The main purpose of these dermatology devices is ...
Breaking Medicine Technology:Building a Best-in-Class Pharma Global Brand Website 2Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5Micro Market Monitor: North American Dermatology Diagnostic Devices Market 2Micro Market Monitor: North American Dermatology Diagnostic Devices Market 3
... President Barack Obama was voted the most powerful person ... nation,s leading weekly healthcare business news magazine. It,s the second ... 100 Most Powerful People in Healthcare. "The passage ... spot for Obama," said Modern Healthcare Editor David ...
... Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior... -- ARDEE, Ireland, Aug. ... ... if (typeof(lpUnit)==,undefined,) var lpUnit=,PRN,; --> ... function(data) { var s = ,; var first_result; // Results are keyed by longUrl, so we ...
Cached Medicine Technology:Obama Named the Most Powerful Person in Healthcare for Second Consecutive Year 2Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 2Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 3Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 4Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 5Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 6Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 7Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 8Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 9Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 10Warner Chilcott Completes Amendment to Existing Senior Secured Credit Facilities and Closes Senior Notes Offering; Company Declares Special Cash Dividend of $8.50 Per Share and Updates Full-Year 2010 Financial Guidance 11
(Date:12/22/2014)... Henderson, Nevada (PRWEB) December 22, 2014 ... out several southern and mid-western cities to have a ... community, TalkLocal ( http://www.talklocal.com ) is launching ... the local economy. , “A strong manufacturing sector ... Henderson,” TalkLocal founder Gurpreet Singh explained, “and TalkLocal works ...
(Date:12/22/2014)... 2014 In recognition of Veteran’s Day, ... Hero Reward, a local organization that provides services to ... , Located on a couple hundred acres in the ... lodging, world class fishing, hunting, hiking, horseback riding, 4-wheeling, ... several years ago to support U.S. Service men and ...
(Date:12/22/2014)... CA (PRWEB) December 22, 2014 ... now offering consultations for sleep apnea. Drowsy drivers are ... than drivers who are well-rested, and some experts believe ... the roads as intoxicated drivers. Unfortunately, millions of Americans ... the American Academy of Sleep Medicine, about 18 million ...
(Date:12/22/2014)... December 22, 2014 7,178 small business ... of Black Friday shopping and opted instead to join ... education company, for their 5th annual “Black Friday Boot ... just $7 to attend the 5 hour online training ... promptly donated to support two Central Texas based charities ...
(Date:12/22/2014)... Luxury Linen purveyor Peacock Alley once again ... provide logistics and support for one of Dallas’ largest holiday ... history of giving back to the community in which it ... Drive were Whataburger® and 99.5 The Wolf. , There is ... gifts to children who would otherwise not receive any is ...
Breaking Medicine News(10 mins):Health News:TalkLocal Launches in Henderson Weeks Following New Megafactory, New Jobs Announcement 2Health News:Discount Labels Donates Portion of November Sales to Hero Reward Program 2Health News:Pasadena Dentist, Dr. Marine Martirosyan, Now Offers Consultations for Sleep Apnea 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 2Health News:Austin Company Digital Marketer Raises 100K to Fight Childhood Cancer 3Health News:Peacock Alley and Community Partners of Dallas Fulfill an Estimated 12,000 Holiday Wishes for Deserving Children 2
... Control Health Care Costs, DALLAS, Oct. 26 ... Cooper, M.D., M.P.H., Cooper Aerobics Enterprises,Inc., announced today ... Aerobics Enterprises purchased Health At Work, a licensed,health, ... division, Cooper Benefits,LLC. Cooper Benefits merges traditional ...
... ST. LOUIS, Oct. 26 The Mattson Jack ... Database(TM). Comorbidity Database(TM) is designed to help ... of the importance of mutually,exclusive and overlapping conditions. ... CNS 2.0, which focuses on mental,health disorders, and ...
... 25, 2007 Shire plc (LSE: SHP, NASDAQ: ... announced that data from a 12-month study of ... Disorder (ADHD) patch, demonstrated that DAYTRANA provided significant ... aged 6 to 12 years. The study ...
... societal problem that needs to be solved. Liver disease, ... the many complications of increased body weight. Treatment options ... unmet need for pharmacologic treatment of this liver disease. ... Dr. Baski-Bey et al. offers a helping hand to ...
... Varian Medical,Systems, (NYSE: VAR ) has been ... by the ServiceTrak(TM) 2007 survey report on radiation,oncology ... that,analyzes service trends in various medical technology sectors ... interviews with,customers. Varian ranked first in 15 ...
... FARMINGTON, Conn., Oct. 26 ConnectiCare has been ranked,#5 ... Report/NCQA America,s Best,Health Plans 2007. The annual rankings are ... moved up one spot from,being ranked #6 in the ... in Connecticut. Mickey Herbert, President and CEO, said, ...
Cached Medicine News:Health News:An Industry First: New Cooper Health Company Makes Group Employee Benefits Consulting and Wellness Program Design a Package Deal 2Health News:An Industry First: New Cooper Health Company Makes Group Employee Benefits Consulting and Wellness Program Design a Package Deal 3Health News:An Industry First: New Cooper Health Company Makes Group Employee Benefits Consulting and Wellness Program Design a Package Deal 4Health News:The Mattson Jack Group, Inc. Announces the Release of the New Comorbidity Database(TM) 2Health News:Long-term 12-month safety data on ADHD patch DAYTRANA 2Health News:Attenuation of NASH by stimulation of free fatty acid metabolism 2Health News:Varian Medical Systems Ranks First in Overall Service Performance in 2007 Survey of U.S. Radiation Oncology Professionals 2Health News:ConnectiCare Ranked #5 Best Health Plan in America 2
... these recommendations with the exceptional design and ... resulted in numerous improvements, such as:, ... holder for hassle-free storage , The system ... a flick of the lever, making transportation ...
The S4 Spinal System has quickly gained a reputation for being the next generation in pedicle screw systems because of its exceptionally small size and high biomechanical strength....
... Diagnostics is a clinical reference ... treatment and monitoring of hemostatic ... a collaboration of four laboratory ... defined vision to deliver customizable ...
All-natural porcine collagen can be used in open or laparoscopic placement....
Medicine Products: