[Federal Register Volume 66, Number 121 (Friday, June 22, 2001)]
[Notices]
[Page 33545]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15720]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0219]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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that the approval of the application be withdrawn and thereby waived 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.

DATES: Effective July 23, 2001.

FOR FURTHER INFORMATION CONTACT: Michael D. Anderson, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION: In a letter to FDA dated October 10, 2000, 
Serono, Inc., voluntarily requested the withdrawal of NDA 17-873 for 
Breokinase (Urokinase for Injection). Serono, Inc., neither 
intends to market the product in the United States nor export it from 
the United States. The firm voluntarily requested that FDA withdraw NDA 
17-873, and therefore has waived its opportunity for a hearing. In a 
December 13, 2000, letter to the firm, FDA acknowledged receipt of the 
request and stated it would proceed (to publish a Federal Register 
notice) withdrawing the NDA.
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(e)) and under authority delegated to the 
Director, Center for Biologics Evaluation and Research (21 CFR 5.82), 
approval of the application listed in this document, and all amendments 
and supplements thereto, is hereby withdrawn, as of July 23, 2001.

    Dated: May 18, 2001.
Kathryn C. Zoon,
Director, Center for Biologics Evaluation and Research.
[FR Doc. 01-15720 Filed 6-21-01; 8:45 am]
BILLING CODE 4160-01-S