US FDA Issues CRL for Certria

RNS Number : 4245J

AstraZeneca PLC

30 March 2010

 



ASTRAZENECA AND ABBOTT RECEIVE FDA COMPLETE RESPONSE LETTER ON CERTRIAD NEW DRUG APPLICATION

AstraZeneca and Abbott announced today that the US 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.

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

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.  The company employs approximately 83,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's web site at www.abbott.com

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30 March 2010

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