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Business · 18/08/2017Updated: 10/17/2026 · 1 min read

FDA Withdraws Approval of BAYCOL Drug Application

Summary

The Food and Drug Administration (FDA) is withdrawing approval of a new drug application for BAYCOL (cerivastatin sodium) tablets in various strengths, submitted by Bayer Healthcare Pharmaceuticals, following Bayer's request to withdraw the application and waive a hearing.

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

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