Serono, Inc.; Withdrawal of Approval of a New Drug Application; Breokinase®

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The Food and Drug Administration (FDA) is withdrawing, without prejudice, approval of a new drug application (NDA) for Breokinase (Urokinase for Injection) held by Serono, Inc., 100 Longwater Circle, Norwell, MA 02061. Serono, Inc., notified the agency in writing that it does not intend to introduce Breokinase into the U.S. market or export Breokinase from the United States, and voluntarily requested that the approval of the application be withdrawn and thereby waived its opportunity for a hearing.