By Bruce Japsen | The U.S. Food and Drug Administration, seeing problems with Abbott Laboratories’ experimental cholesterol drug Certriad, has delayed the compound’s approval.
 
Abbott and AstraZeneca Plc, the British drug giant also developing the capsule with Abbott said this morning the FDA issued the companies a “a complete response letter” for their new drug application. It’s unclear what the problem with the drug is, but an FDA “complete
response” letter typically means the drug has efficacy or safety
concerns and the agency was not going to approve it.

The companies said this morning they are “evaluating the complete
response letter” and “will continue discussions with the FDA to
determine next steps” regarding Certriad.
 
Certriad is a pill that combines a statin drug to lower LDL, or high
cholesterol levels, with a fenobric acid that works to raise HDL, the
so-called good cholesterol. There are myriad cholesterol pills that
achieve similar goals so the public and heart patients are not at risk
of going without a life-saving product, observers say.