FDA issues complete response letter to AstraZeneca, Abbott

WILMINGTON, Del. The Food and Drug Administration has declined to approve an application for a cholesterol drug from AstraZeneca and Abbott, the two drug makers announced Tuesday.

The FDA delivered the companies a complete response letter for Certriad (rosuvastatin and fenofibric acid) delayed-release capsules.

A complete response letter means that the FDA is unable to approve a drug in its current form and usually contains guidance of how to make the drug approvable, though the two companies didn’t specify what issues the agency raised.

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