Zafirlukast is an oral leukotriene receptor antagonist (LTRA) for the maintenance treatment of asthma. It is available as a tablet.

Zafirlukast blocks the action of the cysteinyl leukotrienes on the CysLT1 receptors, thus reducing constriction of the airways, build-up of mucus in the lungs and inflammation of the breathing passages.

Zafirlukast is marketed by AstraZeneca with the brand names Accolate, Accoleit, and Vanticon. It was the first LTRA to be marketed in the USA and is now approved in over 60 countries, including the UK, Japan, Italy, Spain, Canada, Brazil and China.

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CFDA: FDA Latest Computer Systems Warning Letters

WL Issued to Amrex Zetron Inc
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Amrex Zetron Inc on 14 Apr 2009 by Los Angeles District Office
WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Cote, Charles J., MD
FDA Mon, 02 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Cote, Charles J., MD on 02 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Genzyme Corporation
FDA Fri, 27 Feb 2009 00:00:00 -0400
FDA Warning Letter Issued to Genzyme Corporation on 27 Feb 2009 by New England District Office
WL Issued to Hammill Manufacturing Company
FDA Tue, 06 Jan 2009 00:00:00 -0400
FDA Warning Letter Issued to Hammill Manufacturing Company on 06 Jan 2009 by Cincinnati District Office

CFDA: FDA Latest Drug GCP Warning Letters

WL Issued to Coast Institutional Review Board
FDA Tue, 14 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Coast Institutional Review Board on 14 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Branitz, Bruce, MD
FDA Thu, 09 Apr 2009 00:00:00 -0400
FDA Warning Letter Issued to Branitz, Bruce, MD on 09 Apr 2009 by Center for Drug Evaluation and Research
WL Issued to Bukowski, Ronald M, MD
FDA Mon, 30 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Bukowski, Ronald M, MD on 30 Mar 2009 by Center for Drug Evaluation and Research
WL Issued to Youabian, Inc
FDA Tue, 17 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Youabian, Inc on 17 Mar 2009 by Los Angeles District Office
WL Issued to Provena St. Joseph's Medical Center IRB
FDA Thu, 12 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Provena St. Joseph's Medical Center IRB on 12 Mar 2009 by Center for Biologics Evaluation and Research
WL Issued to Paulson, Daniel M., MD
FDA Wed, 11 Mar 2009 00:00:00 -0400
FDA Warning Letter Issued to Paulson, Daniel M., MD on 11 Mar 2009 by Center for Drug Evaluation and Research

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