FDA issues Complete Response Letter for CERTRIAD NDA

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Mar 31 2010Abbott

AstraZeneca and Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD™ (rosuvastatin / fenofibric acid delayed release) Capsules.  The companies are currently evaluating the CRL, will continue discussions with the FDA to determine next steps with respect to the CERTRIAD NDA and will respond to the agency's request for additional information.

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Abbott

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