Bayer Healthcare Pharmaceuticals; Withdrawal of Approval of a New Drug Application for BAYCOL (cerivastatin sodium) Tablets, 0.05 Milligrams, 0.1 Milligrams, 0.2 Milligrams, 0.3 Milligrams, 0.4 Milligrams, and 0.8 Milligrams

摘要

The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 020740 for BAYCOL (cerivastatin sodium) tablets, 0.05 milligrams (mg), 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, and 0.8 mg, held by Bayer Healthcare Pharmaceuticals (Bayer). Bayer requested withdrawal of this application, and has waived its opportunity for a hearing.