Merck Sharp & Dohme Corp.; Withdrawal of Approval of New Drug Applications for VIOXX (Rofecoxib) Tablets and Suspension

الملخص

The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for VIOXX (rofecoxib) Tablets, 12.5 milligrams (mg), 25 mg, and 50 mg, and VIOXX (rofecoxib) Suspension, 12.5 mg/5 milliliter (mL) and 25 mg/5 mL, held by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., P.O. Box 100, 1 Merck Dr., Whitehouse Station, NJ 08889 (Merck). Merck has voluntarily requested that FDA withdraw approval of these applications and has waived its opportunity for a hearing.