[Federal Register Volume 66, Number 158 (Wednesday, August 15, 2001)]
[Notices]
[Page 42869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20574]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0287]


EVSCO Pharmaceuticals, an Affiliate of IGI, Inc.; Withdrawal of 
Approval of NADAs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of two new animal drug applications (NADAs) held by EVSCO 
Pharmaceuticals, an Affiliate of IGI, Inc. In a final rule published 
elsewhere in this issue of the Federal Register, FDA is amending the 
animal drug regulations to remove the portions reflecting approval of 
the NADAs because these products are no longer manufactured or 
marketed.

DATES: Withdrawal of approval is effective August 27, 2001.

FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for 
Veterinary Medicine (HFV-210), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5593.

SUPPLEMENTARY INFORMATION: EVSCO Pharmaceuticals, an Affiliate of IGI, 
Inc., Box 209, Harding Hwy., Buena, NJ 08310, has requested that FDA 
withdraw approval of NADA 32-984 for Cerumite (chloramphenicol, 
prednisolone, tetracaine, and squalane) topical suspension, and NADA 
55-005 for Liquichlor with Cerumene (squalane, pyrethrins, and 
piperonyl butoxide) topical suspension because the products are no 
longer manufactured or marketed.
    Therefore, under authority delegated to the Commissioner of Food 
and Drugs (21 CFR 5.10) and redelegated to the Center for Veterinary 
Medicine (21 CFR 5.84), and in accordance with Sec. 514.115 Withdrawal 
of approval of applications (21 CFR 514.115), notice is given that 
approval of NADAs 32-984 and 55-005 and all supplements and amendments 
are withdrawn effective August 27, 2001.
    In a final rule published elsewhere in this issue of the Federal 
Register, the agency is amending the animal drug regulations to reflect 
the withdrawal of approval of these NADAs.

    Dated: August 6, 2001.
Stephen F. Sundlof,
Director, Center for Veterinary Medicine.
[FR Doc. 01-20574 Filed 8-14-01; 8:45 am]
BILLING CODE 4160-01-S