Navigation Links
Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
Date:12/7/2010

MOUNTAIN VIEW, Calif., Dec. 7, 2010 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Company has scheduled an End-of Review meeting with the U.S. Food and Drug Administration (FDA) in December to discuss the Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for AZ-004 (Staccato loxapine).  Alexza has submitted an Information Package to the FDA in preparation for the meeting, with the responses or proposals to the issues raised in the CRL.  AZ-004 is being developed for the rapid treatment of agitation in schizophrenia or bipolar disorder patients.

The Company anticipates the FDA meeting will be a comprehensive review of the issues identified by the FDA in the CRL, and Alexza's planned responses to those issues.  The Company's primary meeting goal is to clarify and fully understand the key issues, and to establish a plan to respond to those issues.  While the CRL follow-up meeting will be held in December, the Company does not expect the official FDA meeting minutes to be available until at least late January 2011.  The Company anticipates providing a further U.S. regulatory update on AZ-004 after receipt of the official FDA correspondence.

Alexza also announced today that it has met with the European Medicines Agency (EMA) and has received written confirmation that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under the centralized registration procedure.  In addition, Alexza has been notified of the Rapporteur and Co-Rapporteur appointments for the AZ-004 review.  The Company believes that the comprehensive clinical development program for AZ-004 meets the requirements for the MAA filing.  Alexza expects to submit the MAA mid-year 2011.

About Alexza Pharmaceuticals, Inc.

Alexza Pharmaceuticals
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. Alexza Completes Target Enrollment in AZ-104 Phase 2a Clinical Trial in Migraine Patients
2. Alexza Initiates AZ-007 (Staccato(R) Zaleplon) Phase 1 Clinical Trial and Updates Clinical Pipeline Development Status
3. Alexzas AZ-104 (Staccato(R) Loxapine) Phase 2a Trial Meets Primary Endpoint of 2-Hour Pain Relief in Patients with Migraine Headache
4. Alexza Reports 2007 Year-End Financial Results and Updates Clinical Pipeline Status
5. Alexza Announces Positive Phase 1 Results With AZ-007 (Staccato(R) Zaleplon)
6. Alexza Completes Enrollment in Phase 2a Clinical Trial With AZ-002 (Staccato(R) Alprazolam) in Panic Disorder Patients
7. Alexza Pharmaceuticals to Present AZ-004 Phase 2a Clinical Data at the American Psychiatric Association Annual Meeting
8. Alexza Announces Preliminary Results From its AZ-002 (Staccato(R) Alprazolam) Phase 2a Proof-of-Concept Trial in Patients With Panic Disorder
9. Alexza Completes Enrollment in Phase 3 Clinical Trial with AZ-004 (Staccato(R) Loxapine) for Acute Agitation
10. Alexza Pharmaceuticals to Present AZ-104 Phase 2a Clinical Data at the American Headache Society Annual Scientific Meeting
11. Alexza Initiates Second Phase 3 Clinical Trial for AZ-004 (Staccato(R) Loxapine)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... , October 22, 2014 A ... Gloves Market (Product type, Form, End user, Application and ... Insights, Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013 ... gloves market. Based on key trends tracked, it is ... at $7.9 billion by 2020, registering a CAGR of ...
(Date:10/22/2014)... LOUIS , Oct. 21, 2014  Early ... often subtle or unnoticed, but new technology, coupled ... outcomes and leading to earlier detection of eye ... affects 29 million Americans. If left untreated, these ... even blindness. Recently, optometric researchers ...
(Date:10/22/2014)... NEW YORK , Oct. 22, 2014 ... an August 2014 report by Global Research & Data ... 6.2% per year from 2014 through 2018, as demand ... United States is the world,s largest market ... market with advanced thermometers is Sanomedics International Holdings, Inc. ...
Breaking Medicine Technology:Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 2Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 3Global Disposable Gloves Market Expected to Grow to $7.9 Billion by 2020 - Allied Market Research 4Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 2Technology Advancements Enhance Early Detection of Eye Diseases Associated with Diabetes 3Sanomedics International Holdings Analyst Report: Taking Some Heat by BrokerBank Securities, Inc. 2
(Date:10/22/2014)... 22, 2014 Lintelus, Inc., an event ... President of Sales, will be speaking on the subject ... Expo on October 28, at the Holiday Inn in ... booth as well as a Tech Demo at 12:45pm, ... create a more engaging event experience. , The Annual ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, 2014 (HealthDay ... be showing a genetic propensity for obesity as toddlers, a ... linked to increased body fat, but the same genes in ... researchers said. At 1 year, kids with these genes ... however, these genes were linked to excessive weight gain, the ...
(Date:10/22/2014)... Tara Haelle HealthDay Reporter ... drinking among young adult men may lead to increased blood ... didn,t cause a similar rise in blood pressure for young ... fact, when young adult women drank lightly or moderately, their ... study found. "This finding parallels studies in older adult ...
(Date:10/22/2014)... HealthDay Reporter , MONDAY, Oct. 20, 2014 (HealthDay ... for health workers treating Ebola patients, now requiring full body ... at all times. The U.S. Centers for Disease Control ... Dallas nurses contracted Ebola while caring for the first ... Duncan. Nina Pham is currently being treated for her infection ...
(Date:10/20/2014)... Orlando, Florida (PRWEB) October 20, 2014 ... fired-up former Gov. Charlie Crist made a brief fundraising ...  in Orlando on Thursday. , Fresh from a debate ... refused to take the stage for the first seven ... podium, the former governor described the incident in one ...
Breaking Medicine News(10 mins):Health News:Jay Cormier, Sr. Vice President of Sales for Lintelus, Speaks about Event Technology Integration at Meetings Technology Expo in NYC 2Health News:Tall, Heavy 1-Year-Olds May Be at Risk for Obesity Later, Study Finds 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4Health News:CDC Tightens Rules on Caring for Ebola Patients 2Health News:CDC Tightens Rules on Caring for Ebola Patients 3Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 2Health News:At Crist Fundraiser, Dan Newlin Says, "No More Robert Germans," Will Seek Changes to Florida Missing Persons Law 3
... Union asks board member to seek restatement of Beth ... Staples director Martin Trust,should apply the same Sarbanes-Oxley standards ... role on the board of Beth Israel Deaconess,Medical Center ... East. Trust is the CEO of Samtex and a ...
... Advisory Board Company,(Nasdaq: ABCO ) announced today ... Michael T. Kirshbaum, Chief Financial Officer and Robert,Musslewhite, ... upcoming investor conferences., Mr. Williams will present ... at,the UBS 18th Annual Global Healthcare Services Conference, ...
... in Long-Term Care: A Board of Directors Dashboard, ... Office of Inspector General (OIG) for the Department of ... Association (HCCA),present the challenges and opportunities for the boards ... of Care Dashboard." A,Quality of Care Dashboard is a ...
... Fla., Feb. 6 Mangrove Employer Services, a,leading ... Payroll, Benefits Administration and Self Service solutions,announces the ... Mangrove Employer Services teamed up with an ... in electronic benefits,payment services, in 2007 to provide ...
... NAPA, Calif., Feb. 6 Senetek PLC (OTC,Bulletin ... the development,of technologies that target the science of ... on Pyratine-6(TM) at the 66th Annual Meeting,of the ... In his presentation to the Academy, Dr. ...
... after , , WEDNESDAY, Feb. 6 (HealthDay News) -- An advanced ... harbingers of Alzheimer,s disease, can develop in just 24 hours. ... Hyman, leader of the group reporting the finding in the ... develop, damage is evident in nearby nerve cells almost immediately, ...
Cached Medicine News:Health News:Staples Board Member Should Use Sarbanes-Oxley Disclosure Rules in Non-Profit Role, Asserts 1199 SEIU 2Health News:The Advisory Board Company to Present at Upcoming Conferences 2Health News:OIG and HCCA Issue Government-Industry Roundtable Report 2Health News:Mangrove Announces Health Savings Account (HSA) and Health Reimbursement Account (HRA) Product Launches 2Health News:Dr. Neil Sadick Presents on Pyratine-6(TM) at the Annual Meeting of the American Academy of Dermatology 2Health News:Alzheimer's Plaques Can Form in One Day 2
... Amvex offers a complete line of flowmeters, available ... are all available in a variety of calibrations to ... dials specific to the gas in use, the Amvex ... colors replace the U with I. For Power Take-Off ...
0-3.5 LPM Oxygen Flowmeter with Chemetronmale inlet...
0-15 LPM Oxygen Flowmeter with Chemetron male inlet...
(1/4-15 LPM). 50 psi back inlet, wall mounted, 1/8" NPT female....
Medicine Products: