[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27196]


[[Page Unknown]]

[Federal Register: November 3, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 94N-0392]

 

Fujisawa USA, Inc; Withdrawal of Approval of a New Drug 
Application

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of a new drug application (NDA) held by Fujisawa USA, Inc., Parkway 
North Center, Three Parkway North, Deerfield, IL 60015-2548 (Fujisawa). 
FDA is withdrawing approval of this application because of questions 
raised about the reliability of the data and information submitted to 
FDA in support of the application. Marketing of the drug has been 
discontinued, and Fujisawa has voluntarily requested withdrawal of 
approval of the application and has waived its opportunity for a 
hearing.

EFFECTIVE DATE: November 3, 1994.

FOR FURTHER INFORMATION CONTACT: Tamar S. Nordenberg, Center for Drug 
Evaluation and Research (HFD-366), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION:  Recently, FDA became aware of discrepancies 
in the data used to support approval of the following NDA held by 
Fujisawa:
    NDA 18-440, M.V.C. 9+3.
    Fujisawa has identified discrepancies in data submitted to obtain 
approval of the application listed above, which have raised questions 
about the reliability of the data. In a letter dated February 22, 1994, 
Lyphomed requested withdrawal of this 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 Drug Evaluation and Research (21 CFR 5.82), 
approval of the NDA listed above, and all amendments and supplements 
thereto, is hereby withdrawn, effective November 3, 1994. Distribution 
of drug products in interstate commerce without an approved application 
is unlawful.

    Dated: October 24, 1994.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 94-27196; Filed 11-2-94; 8:45 am]
BILLING CODE 4160-01-F