Announced today that it has resubmitted its AZ-004 New Drug Program to the U.

Alexza resubmits AZ-004 NDA for treatment of agitation in schizophrenia patients Alexza Pharmaceuticals, Inc. announced today that it has resubmitted its AZ-004 New Drug Program to the U .S. Food and Drug Administration in response to a Complete Response Letter received in October 2010. In addition to the data from the original NDA and additional analyses of some of those data, the AZ-004 resubmission contains brand-new data from the finished individual factors study successfully, stability data from fresh production batches manufactured last year late, updated manufacturing and settings sections addressing findings from the business’s Pre-Acceptance Inspection, and up to date draft labeling and a thorough REMS proposal..

(Arch Pediatr Adolesc Med. 2009;163[3]:211-217. Notice: This study is funded by a grant from the National Institute on Alcoholic beverages Abuse and Alcoholism. Start to see the article for additional information Please, including other authors, author contributions and affiliations, financial disclosures, support and funding, etc. Editorial: Action Needed to Regulate Alcohol-Branded Merchandise The data is solid that youth exposure to alcohol marketing increases the likelihood of early initiation, which puts teenagers at greater threat of alcohol-related harm, writes David H. Jernigan, Ph.D., of the Johns Hopkins Bloomberg College of Public Health, Baltimore, in an accompanying editorial.