AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application

AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug
Application

AstraZeneca has received a Complete Response Letter (CRL) from the U.S.
Food and Drug Administration (FDA) for the new drug application for
AXANUMTM (aspirin/esomeprazole magnesium) tablets.  The company also
received a CRL for the supplemental new drug application (sNDA) for
NEXIUM® (esomeprazole magnesium).

 

AstraZeneca is currently evaluating the CRLs, and will continue
discussions with the FDA to determine next steps with respect to both
the AXANUM NDA as well as the NEXIUM sNDA and will respond to the
agency's request for additional information.

 

AstraZeneca submitted both applications to the FDA on April 30, 2009,
seeking approval for AXANUM, for the risk reduction of low dose
ASA-associated gastric and/or duodenal ulcers in patients at risk. The
NEXIUM sNDA was submitted for the risk reduction of low-dose
aspirin-associated peptic ulcers.

 

NOTES TO EDITORS:

 

About AxanumTM

Axanum is a fixed-dose combination containing low-dose ASA
(acetylsalicylic acid) and the active ingredient of the PPI Nexium®
(esomeprazole, formulated as enteric coated pellets) developed by
AstraZeneca for the prevention of cardio- and cerebrovascular (CV)
events in patients requiring continuous low-dose ASA treatment, and at
risk for developing ASA associated gastric and/or duodenal ulcers.

 

 

About AstraZeneca

 AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and commercialisation
of prescription medicines.  As a leader in gastrointestinal,
cardiovascular, neuroscience, respiratory and inflammation, oncology and
infectious disease medicines, AstraZeneca generated global revenues of
US $32.8 billion in 2009.  For more information please visit:
www.astrazeneca.com (http://www.astrazeneca.com/)