Hoechst Marion Roussel, Inc., and Baker Norton Pharmaceuticals, Inc.; Terfenadine; Withdrawal of Approval of Two New Drug Applications and One Abbreviated New Drug Application

摘要

The Food and Drug Administration (FDA) is withdrawing approval of two new drug applications (NDA's) and one abbreviated new drug application (ANDA) for drug products containing terfenadine. NDA 18-949 (Seldane) and NDA 19-664 (Seldane-D) are held by Hoechst Marion Roussel, Inc. (HMR), 10236 Marion Park Dr., Kansas City, MO 64134. ANDA 74-475 is held by Baker Norton Pharmaceuticals, Inc. (Baker Norton), 4400 Biscayne Blvd., Miami, FL 33137. The basis for the action is a finding that terfenadine is not shown to be safe for use in the treatment of seasonal allergic rhinitis. HMR and Baker Norton waived their opportunity for a hearing. No other party has requested a hearing.