[Federal Register Volume 62, Number 193 (Monday, October 6, 1997)]
[Notices]
[Pages 52137-52138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26353]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96P-0181]


Determination that Chlorhexidine Gluconate Topical Tincture 0.5% 
Was Withdrawn From Sale for Reasons of Safety

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
chlorhexidine gluconate topical tincture 0.5% (Hibitane) was 
withdrawn from sale for reasons of safety. The agency will not accept 
abbreviated new drug applications (ANDA's) for chlorhexidine gluconate 
topical tincture 0.5%.

FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress passed into law the Drug 
Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-
417) (the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors must, with certain exceptions, show that the drug for which 
they are seeking approval contains the same active ingredient in the 
same strength and dosage form as the listed drug, which is a version of 
the drug that was previously approved under a new drug application 
(NDA). Sponsors of ANDA's do not have to repeat the extensive clinical 
testing otherwise necessary to gain approval of an NDA. The only 
clinical data required in an ANDA are data to show that the drug that 
is the subject of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments included what is now section 505(j)(6) of the 
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(j)(6)), 
which requires FDA to publish a list of all approved drugs. FDA 
publishes this list as part of the ``Approved Drug Products with 
Therapeutic Equivalence Evaluations,'' which is generally known as the 
``Orange Book.'' Under FDA regulations, drugs are withdrawn from the 
list if the agency withdraws or suspends approval of the drug's NDA or 
ANDA for reasons of safety or effectiveness, or if FDA determines that 
the listed drug was

[[Page 52138]]

withdrawn from sale for reasons of safety or effectiveness 
(Sec. 314.162 (21 CFR 314.162)).
    FDA regulations provide that any person may petition the agency for 
a determination as to whether a listed drug has been voluntarily 
withdrawn from sale for reasons of safety effectiveness 
(Sec. 314.161(b) (21 CFR 314.161(b))). Richard A. Hamer submitted a 
citizen petition dated May 24, 1996, under 21 CFR 10.25(a), 10.30, and 
314.122(a), requesting that the agency determine whether chlorhexidine 
gluconate topical tincture 0.5% (Hibitane) was withdrawn from 
sale for reasons of safety or effectiveness. Zeneca Pharmaceuticals 
(formerly Steuart Pharmaceuticals and ICI Americas) obtained approval 
of NDA 18-049 for chlorhexidine gluconate topical tincture 0.5% on 
December 18, 1978, as a patient preoperative skin preparation. The 
product was withdrawn from sale by the sponsor in early 1984. Because 
the sponsor discontinued marketing of the product, the agency currently 
lists chlorhexidine gluconate topical tincture 0.5% in the Orange 
Book's ``Discontinued Drug Product List.''
    FDA has reviewed its records and, under Secs. 314.161 and 
314.162(a)(2), has determined that chlorhexidine gluconate topical 
tincture 0.5% was withdrawn from sale for reasons of safety. 
Specifically, the product was withdrawn because of the significant 
number of reports received concerning chemical and thermal burns 
associated with the use of the product. Therefore, chlorhexidine 
gluconate topical tincture 0.5% will be removed from the list of drug 
products with effective approvals published in FDA's publication, 
``Approved Drug Products with Therapeutic Equivalence Evaluations.'' 
FDA will not accept ANDA's that refer to this drug product.

    Dated: September 26, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-26353 Filed 10-3-97; 8:45 am]
BILLING CODE 4160-01-F