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Business · 22/06/2001Updated: 10/17/2026 · 1 min read

Serono, Inc. Seeks Withdrawal of FDA Approval for Breokinase

Summary

Serono, Inc. has requested the FDA to withdraw its approval of a new drug application for Breokinase, a urokinase injection, due to the company's decision not to introduce the drug into the US market or export it from the US.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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