FDA delays approval of Certriad (rosuvastatin/fenofibric acid combo) 1

Abbott and AstraZeneca today announced receipt from the FDA of a complete response letter (CRL) for Certriad, their combination of Abbott’s TriLipix (fenofibric acid) and AstraZeneca’s Crestor (rosuvastatin). The companies did not provide details on the contents of the letter, but Wall Street analysts are predicting that the CRL means that Certriad’s approval will be, at best, delayed until next year. The letter follows by a few weeks the presentation at the ACC of the ACCORD trial results, which found no benefit for the combination of simvastatin and fenofibric acid over simvastatin alone in type 2 diabetics.

Click here to download a copy of the Leerink Swann research report.

Here is the Abbott and AstraZeneca press release:

AstraZeneca and Abbott Receive FDA Complete Response Letter on CERTRIAD(TM) New Drug Application

WILMINGTON, Del. and ABBOTT PARK, Ill., March 30 /PRNewswire-FirstCall/ — 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.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization 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. In the United States, AstraZeneca is a $14.8 billion dollar healthcare business.
For more information about AstraZeneca in the US or the AZ&Me™ Prescription Savings programs, please visit: http://www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

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 http://www.abbott.com.

SOURCE Abbott

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