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

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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.