TITLE

FDA Issues CRL for Alexza Pharmaceuticals' Adasuve

AUTHOR(S)
Shaffer, Catherine
PUB. DATE
May 2012
SOURCE
BioWorld Today;5/7/2012, Vol. 23 Issue 88, p1
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
This article reports on the decision of the U.S. Food and Drug Administration (FDA) to issue a complete response letter for Alexza Pharmaceuticals Inc.'s Adasuve inhalation powder for agitation in schizophrenia and bipolar disorder. According to the company, the agency cited manufacturing deficiencies and the lack of new clinical or safety issues identified. Details on the clinical trial of the drug are given.
ACCESSION #
75286827

 

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