The FDA has informed Abbott Laboratories that it needs more time to review the company’s cholesterol drug TriLipix.
Abbott spokesman Scott Stoffel said that the company continues to expect approval of TriLipix by the end of the year, despite an anticipated October approval.
The FDA has not asked for more data from Abbott to complete the review, Stoffel said.
TriLipix is designed to treat unhealthy levels of lipids and triglycerides. Abbott applied for FDA approval for its use as a solo drug and in combination with statins. TriLipix is a follow-up to Abbott's TriCor, which had $886 million in sales for the first nine months of 2008. As TriCor faces the threat of generic competition, TriLipix would provide a newer, patent-protected offering for Abbott.