AstraZeneca Receives FDA Complete Response Letter for AXANUM New Drug Application, Astra Zeneca

Release Date: 2010-06-01

AstraZeneca has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the new drug application for AXANUM (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.
Type: NORMAL
Company: Astra Zeneca
Country: 意大利
 
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