Navigation Links
Alexza Receives Complete Response Letter for Adasuve™ NDA
Date:5/3/2012

MOUNTAIN VIEW, Calif., May 3, 2012 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ADASUVE™ (loxapine) inhalation powder, 5 mg and 10 mg.  The CRL was issued by FDA's Center for Drug Evaluation and Research indicating that the NDA review cycle is complete and the application is not ready for approval in its present form.  ADASUVE is being developed for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

In the CRL, the FDA noted, "During a recent inspection of the Mountain View, CA manufacturing facility for this application, our field investigator conveyed deficiencies to the representative of the facility.  Satisfactory resolution of these deficiencies is required before this application may be approved."  Alexza believes the deficiencies are medical device specific and readily addressable.  Alexza plans to meet with the FDA to gain a better understanding of the specific deficiencies and this meeting will be scheduled as soon as practical.  Alexza looks forward to working to resolve the remaining issues in a timely manner.

There were no new clinical or safety issues identified and there were no other deficiencies outlined in the CRL.  With respect to the ADASUVE Risk Evaluation and Mitigation Strategy (REMS), the CRL stated that discussions can continue on the proposed REMS after the response to the action letter has been submitted.  The CRL also contained comments on Alexza's draft product labeling.  Alexza believes that there is substantial agreement between Alexza and the FDA on the REMS and product labeling.

Conference Call Information - 8:00 a.m. Eastern Time on May 4, 2012
To a
'/>"/>

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

Page: 1 2 3 4

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:1/15/2014)... Jan. 15, 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act ... tender offer by its indirect wholly-owned subsidiary, Sapphire Subsidiary ... common stock of Solta Medical, Inc. (NASDAQ: ...
(Date:1/15/2014)...  A novel wearable injector slightly larger than an Oreo cookie ... self-inject prescription drugs in the large doses required to treat ... deficiencies, and genetic disorders.  An emerging biologic ... according to analysts.   Many of these drugs will require a ...
(Date:1/14/2014)... The Brandeis Medical Center, led by Dr. Emmanuel Brandeis ... affordable laser tattoo removal experience with the advanced Astanza Duality laser ... high quality cosmetic services with cutting edge medical technology and offering ... California has seen a dramatic increase in the presence ...
Breaking Medicine Technology:Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3Enable Injections Presents A New Class of Injectors for Drug Delivery at PEPTalk, Drug Delivery Partnership Meetings 2Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2
(Date:7/9/2014)... may smell of flatulence and have a reputation for being ... hydrogen sulfide is now being being found to offer potential ... stroke, heart attacks and dementia. A new compound (AP39), designed ... key to future therapies, by targeting delivery of very small ... inside cells. , Scientists in Exeter have already found ...
(Date:7/9/2014)... most important organs in the human body. Its job ... this is its synthesis function and that ... is its detoxification function. Lack of exercise and too ... liver. The resulting diseased cells can lead to inflammations, ... According to the German Liver Foundation, over five million ...
(Date:7/9/2014)... printing on prescription labels handed out by pharmacists ... in taking medication, according to new research by ... Institute for the Blind)., The study, published recently ... that labels on prescription medications dispensed by pharmacies ... legibility. , By simply following recommended guidelines for ...
(Date:7/9/2014)... , , , , ... , , , , ... rifle and the microphone is 50m downrange from the firer and approximately 30cm from the bullet... , ... , , , , , , ... , , , , , , , ...
(Date:7/9/2014)... diseases has risen dramatically in Western societies. One frequently ... microorganisms and have fewer infections than previous generations, thereby ... by researchers at Sahlgrenska Academy, University of Gothenburg, monitored ... of the immune system in relation to allergic disease. ... the Vstra Gtaland Region, half of them on farms ...
Breaking Medicine News(10 mins):Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Telemedicine for patients with chronic liver diseases 2Health News:Telemedicine for patients with chronic liver diseases 3Health News:Most prescription labels fail to meet guidelines, risking dosage errors 2Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 2Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 3Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 4Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 5Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 6Health News:Fit for the frontline? New study identifies the hearing requirements of British soldiers 7
... SATURDAY, Oct. 1 (HealthDay News) -- Halloween candy may ... unexpected allergy and asthma triggers that can pose a ... makeup, according to experts from the American College of ... of Halloween-associated allergies, they focus on candy and often ...
... 30, 2011Young adults undergoing addiction treatment arrive ready and ... recovery, but it,s the help and guidance received during ... a longitudinal study published electronically and in press within ... study was conducted collaboratively by the Center for Addiction ...
... late nineties, researchers from a promising yet volatile French ... their own horse. The seven founders teamed-up with ... industry and with Gemmes Ventures, an investment fund specialising ... names such as Rotschild are backing CrossJect, which is ...
... Ph.D., vice president of research for Lifespan ( www.lifespan.org ), ... the annual ceremony last night at Harvard University. Snyder, along ... and Yale Medical School, were recognized for their work which ... have the same impact on impairing cognitive function as small ...
... A program designed to accelerate the entry of ... following completion of their graduate research degree or ... National Institutes of Health Director,s Early Independence Awards ... empower the biomedical research workforce, particularly through the ...
... Men over 75 with prostate cancer who are otherwise healthy ... study. Meanwhile, younger men with prostate cancer who ... -- are being treated for their cancer, but not responding ... researchers found. "This study suggests that men with certain ...
Cached Medicine News:Health News:Halloween Trappings Can Trigger Asthma, Allergies 2Health News:Study shows young adults want to recover from addiction but need help to make it happen 2Health News:An innovation star for Europe 2Health News:An innovation star for Europe 3Health News:Lifespan researcher wins Ig Nobel Prize 2Health News:NIH program allows junior investigators to bypass traditional post-doc training 2Health News:Otherwise Healthy Older Men Undertreated for Prostate Cancer: Study 2Health News:Otherwise Healthy Older Men Undertreated for Prostate Cancer: Study 3
125I radioimmunoassay, Simple extraction procedure, Ready-to-use calibrators, Less than 0.1% crossreactivity with DHEA-SO4, 2-hour single incubation, 37C, Calibration Range: 0.5 30 ng/mL...
Inquire...
EL-RF/3 is for measurement of IgM, IgG, IgA RF with high specificity for rheumatoid arthritis....
Rapid latex slide agglutination assay for the qualitative and semi-quantitative determination of Rheumatoid Factors in human serum....
Medicine Products: