Navigation Links
Alexza Pharmaceuticals Completes End-of-Review Meeting With FDA for AZ-004 (Staccato® Loxapine) NDA
Date:1/18/2011

eview period will be 6 months.

The CRL also raised issues relating to the suitability of the stability studies undertaken by Alexza and certain other items relating to the Agency's pre-approval manufacturing inspection, which was completed in August 2010.  Alexza believes it understands these issues and that the issues can be adequately addressed in the AZ-004 NDA resubmission.

Since AZ-004 incorporates a novel delivery system, the CRL included input from FDA's Center for Devices and Radiological Health (CDRH).  In the CRL, CDRH requested a human factors study and related analysis to validate that the product can be used effectively in the proposed clinical setting.  Prior to the End-of-Review meeting, Alexza provided a human factors study draft protocol for review by CDRH, on which the FDA provided input and comments.  Alexza expects to finalize the protocol with the FDA and complete this study in the coming months.  Alexza is not required to conduct any additional efficacy or safety clinical trials.

CDRH also requested further bench testing of the product under an additional "worst-case" manufacturing scenario.  Alexza has completed this additional "worst-case" bench testing of the product, submitted data to the FDA and believes that this issue has been adequately addressed.

Conference Call Information

The Company will host an investor conference call and live webcast later today, Tuesday, January 18, 2011, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time.  The conference call, live webcast and archived replay are open to all interested parties.

To access the conference call via the Internet, go to www.alexza.com, under the "Investor Relations" link.  Please join the call at least 15 minutes prior to the start of the call to ensure time for any software downloads that may be required.  Interested parties may also pre-regis
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. Alexza Pharmaceuticals Provides Regulatory Update for AZ-004 (Staccato® Loxapine)
2. Alexza Pharmaceuticals Reports 2010 Third Quarter Financial Results and Provides Business Update
3. Alexza Pharmaceuticals to Announce 2010 Third Quarter Financial Results on November 9, 2010
4. Alexza Pharmaceuticals Reacquires U.S. and Canadian Rights for AZ-004 (Staccato® Loxapine)
5. Valeant Pharmaceuticals Announces That Alexza Pharmaceuticals Has Received a Complete Response Letter for AZ-004 (Staccato® Loxapine) Inhalation Aerosol NDA
6. Alexza Pharmaceuticals Receives Complete Response Letter for AZ-004 (Staccato® Loxapine) NDA
7. Alexzas Staccato® Nicotine Licensed to Cypress Bioscience
8. Alexza Pharmaceuticals to Present at Bank of America Merrill Lynch 2010 Specialty Pharmaceuticals Conference
9. Alexza Pharmaceuticals Appoints Joseph L. Turner to Its Board of Directors
10. Alexza to Announce 2010 Second Quarter Financial Results on Monday, July 26, 2010
11. Alexza Pharmaceuticals Updates Staccato® Pipeline and Outlines Pipeline Development Strategy
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... Ky. , Jan. 15, 2014  Manufacturers, suppliers ... must be able to protect their most important ... http://photos.prnewswire.com/prnh/20130716/CL46586LOGO ) Because of ... it steadfastly remains one of the most litigious ...
(Date:1/15/2014)... , Jan. 15, 2014  Echo Therapeutics, Inc. (Nasdaq: ... its Symphony® CGM System as a non-invasive, wireless continuous ... Doman , Executive Chairman and Interim CEO of Echo ... Tenth Annual Equity Conference. Mr. Doman ...
(Date:1/15/2014)... 15, 2014 Reportlinker.com announces that a ... its catalogue: PharmaPoint: ... Market Analysis to 2022 ... - India Drug Forecast and Market Analysis ...
Breaking Medicine Technology:Intellectual Property Insurance for Medical-related Products and Services 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 2Echo Therapeutics to Present at the Noble Financial Capital Markets' Tenth Annual Equity Conference 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5
(Date:4/17/2014)... NY In a review published in the April ... president of The Feinstein Institute for Medical Research, says ... medical community,s approach to treating sepsis, which ... Americans. , Sepsis occurs when molecules released into the ... throughout the body. Inflammation is necessary for maintaining good ...
(Date:4/17/2014)... synthetic biology team has created a new technology ... that could travel the body and selectively target ... cell-based, biological devices that monitor and modify human ... biology. However, no existing technology enabled bioengineers to ... state and respond in a customized fashion. , ...
(Date:4/17/2014)... Doctors who treat patients with a severe and ... an agonizing treatment decision. , The drug sirolimus ... relieve shortness of breath. But some patients eventually ... potentially fatal complications following transplantation. , "It,s a ... director of Loyola University Medical Center,s LAM Clinic ...
(Date:4/17/2014)... NY (April 16, 2014) The cause of neuronal ... new study proposes that neurons may be mistaken for ... system, similar to the way autoimmune diseases like type ... body,s cells. The study was published April 16, 2014, ... new, and likely controversial, idea in Parkinson,s disease; but ...
(Date:4/17/2014)... By discovering a new mechanism that allows blood ... at UC Irvine and the Salk Institute have opened ... prevent stroke-induced brain damage. , A complex and devastating ... and primary reason for disability in the U.S. The ... lets blood-borne material into the brain, causing the permanent ...
Breaking Medicine News(10 mins):Health News:Feinstein Institute researcher publishes new perspective on sepsis 2Health News:Building 'smart' cell-based therapies 2Health News:Patients with rare lung disease face agonizing treatment dilemma 2Health News:Patients with rare lung disease face agonizing treatment dilemma 3Health News:Is Parkinson's an autoimmune disease? 2Health News:Study IDs new cause of brain bleeding immediately after stroke 2
... water to Sun City, Sun City West, and Town of Youngtown ... Arizona American Water will supply water to emergency services providers ... as part of an organized effort by the Salvation Army to ... in the Arizona desert easily exceed 110 degrees in the summer ...
... Co-Host of Innovative Medical Program , , BEVERLY HILLS, ... syndicated talk show The Doctors, is pleased to ... Daytime Emmy Award in the Outstanding Talk Show/Informative category. , ... of Television Arts & Sciences has selected us for such ...
... million are an hour or more away from quality treatment, ... of children in the United States live more than an ... trauma center, an amount of time that could prove deadly ... In the United States, more children aged 1-14 die of ...
... Advisories led to ,unintended consequences, researchers say , MONDAY, ... depression in America have dropped sharply since the government,s ... children and teens taking antidepressants, a new analysis finds. ... U.S. Food and Drug Administration,s advisories about the use ...
... stroke occurs, it often comes within a day, study shows, ... people who have a major stroke soon after a less ... "mini-stroke," do so within 24 hours of the minor event, ... who have a TIA is to "seek medical attention immediately, ...
... A new study released today of more than 20,000 men ... more than two decades of the number of adults with ... screening instruments to identify individuals entering jails with the most ... continuous treatment, a team of researchers from the nonpartisan Council ...
Cached Medicine News:Health News:Arizona American Water and Salvation Army Offer Aid on Hottest Days 2Health News:Respected Surgeon Receives Emmy Nomination 2Health News:1 in 3 U.S. Kids Lack Nearby Trauma Care 2Health News:Depression Treatment Wanes Following FDA Warnings 2Health News:Depression Treatment Wanes Following FDA Warnings 3Health News:Mini-Stroke Can Mean Major One Within Hours 2Health News:Mini-Stroke Can Mean Major One Within Hours 3Health News:New Study Documents High Prevalence of Serious Mental Illnesses Among Nation's Jail Populations 2
... TS100 is an innovative and efficient ... tool complements any research facility. Improved ... Nikon offers the TS100 binocular and ... model comes with a photo port ...
... video camera. Olympus wide array of high-quality color ... and flexibility you need for an efficient viewing ... image of your specimen that can be easily ... can even record movies when these easy-to-operate cameras ...
... video camera with digital signal processing. Olympus ... give you all the image quality and ... experience. These video cameras provide a high-resolution, ... be easily observed on a video monitor ...
... This latest model in the PM ... the tasks required for routine brightfield ... general industrial photography. Remarkably economical in,price, ... highly functional mechanisms which meet the ...
Medicine Products: