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AstraZeneca and Abbott Receive FDA Complete Response Letter on CERTRIAD NDA

Tue, 03/30/2010 - 5:15am

AstraZeneca and Abbott announced today that the FDA issued a complete response letter (CRL) for the New Drug Application (NDA) for CERTRIAD(TM) (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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