FDA took the unusual step of withdrawing approval of two cholesterol-lowering drugs late last week.
FDA withdrew approval of 2 cholesterol-lowering drugs late last week, and the manufacturer pulled the drugs off the market.
The agency withdrew the new drug applications (NDAs) for niacin extended-release (ER) and lovastatin tablets (Advicor, AbbVie) and niacin ER and simvastatin (Simcor, AbbVie) tablets.
Related: FDA approves major cholesterol drug
After reviewing the collective evidence from several large cardiovascular outcome trials, FDA concluded that “the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events,” the agency stated.
AbbVie requested that FDA withdraw approval of the applications and has waived its opportunity for a hearing, according to the agency.
“FDA has also determined that Advicor and Simcor were withdrawn from sale for reasons of safety and effectiveness, and FDA will not accept or approve abbreviated new drug applications (ANDAs) that reference Advicor or Simcor,” the agency said in a notice published in the Federal Register.
FDA approved Advicor back in 2001 and Simcor in 2008.