AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules

الملخص

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the indications related to the coadministration with a statin for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules. Affected applications include one new drug application (NDA) and seven abbreviated new drug applications (ANDAs) for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing.