[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Notices]
[Pages 68289-68290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98P-0221]


Zeneca, Inc.; Withdrawal of Approval of Portion of a New Drug 
Application Providing for a Formulation of Diprivan Injectable Emulsion 
Not Containing Disodium Edetate

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of those portions of a new drug application (NDA) held by 
Zeneca, Inc., (Zeneca) for Diprivan (propofol) Injectable Emulsion that 
provide for a formulation not containing the antimicrobial additive 
disodium edetate.

EFFECTIVE DATE: December 10, 1998.
FOR FURTHER INFORMATION CONTACT:  Virginia G. Beakes, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION:  By citizen petition dated April 7, 1998 
(Docket No. 98P-0221/CP1), Zeneca, 1800 Concord Pike, Wilmington, DE 
19850, requested that FDA withdraw approval of those portions of NDA 
19-627 that provide for a formulation of Diprivan Injectable Emulsion 
that does not contain the antimicrobial additive disodium edetate, 
stating that the company discontinued marketing the product because of 
potential contamination problems observed after approval of the NDA. 
Zeneca waived its opportunity for a hearing.

[[Page 68290]]

     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 those portions of NDA 19-627 that provide for a formulation 
of Diprivan Injectable Emulsion that does not contain the antimicrobial 
additive disodium edetate is hereby withdrawn effective December 10, 
1998.
    Dated: November 16, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-32742 Filed 12-9-98; 8:45 am]
BILLING CODE 4160-01-F