CertriadTreatment for Hyperlipidemia, Hypertriglyceridemia, Hyperlipoproteinemia
Complete Response Letter for Certriad
AstraZeneca and Abbott Receive FDA Complete Response Letter on Certriad New Drug Application
WILMINGTON, Del. and ABBOTT PARK, Ill., March 30, 2010 /PRNewswire via COMTEX/ --AstraZeneca and Abbott 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.
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: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).
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.
Posted: March 2010
- Abbott and AstraZeneca End License Agreement for the Development of Certriad - December 22, 2010
- Abbott and AstraZeneca Submit New Drug Application to the FDA for Certriad, an Investigational Treatment for Mixed Dyslipidemia - June 4, 2009