[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] ----------------------------------------------------------------------- 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.
-----------------------------------------------------------------------
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.
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formulation of Diprivan Injectable Emulsion that does not contain the antimicrobial additive disodium edetate is hereby withdrawn effective December 10, 1998.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