AstraZeneca and Abbott announced 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 US 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 commercialisation of prescription medicines.
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.