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Business · 18/04/2016Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of Indications for Niacin ER Tablets and Fenofibric Acid DR Capsules

Summary

The US Food and Drug Administration (FDA) has withdrawn its approval of indications for the coadministration of niacin extended-release tablets and fenofibric acid delayed-release capsules with statins, following a request from the applicants, AbbVie Inc. and others, who waived their right to a hearing.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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