[Federal Register Volume 66, Number 187 (Wednesday, September 26, 2001)]
[Notices]
[Pages 49193-49194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24039]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01P-0245]


Determination That Disulfiram Tablets, 250 and 500 Milligrams, 
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
disulfiram (Antabuse) 250- and 500-milligram (mg) tablets, formerly 
marketed by Wyeth Ayerst Pharmaceuticals (Wyeth Ayerst), were not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) for disulfiram 
drug products, and it will allow FDA to continue to approve ANDAs for 
disulfiram 250- and 500-mg tablets.

FOR FURTHER INFORMATION CONTACT: Mary E. Catchings, Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20855, 301-594-2041.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (the 1984 
amendments) (Public Law 98-417), 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 
drug selected by the agency as the reference standard for 
bioequivalence testing. Sponsors of ANDAs do not have to repeat the 
extensive clinical testing otherwise necessary to gain approval of a 
new drug application (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 to which the ANDA refers.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), 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,'' 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 
withdrawn from sale for reasons of safety or effectiveness (21 CFR 
314.162).
    Under Sec. 314.161(a)(2) (21 CFR 314.161(a)(2)), the agency must 
make a determination as to whether a listed drug was withdrawn from 
sale for reasons of safety or effectiveness if ANDAs that refer to the 
drug that was withdrawn are approved. Section 314.161(d) provides that 
if FDA determines that the listed drug was removed from sale for safety 
or effectiveness reasons, the agency will

[[Page 49194]]

begin proceedings to withdraw approval of the ANDAs that refer to the 
drug that was withdrawn from sale.
    On May 4, 2001, Sidmak Laboratories, Inc. (Sidmak), submitted a 
citizen petition (Docket No. 01P-0245/CP1) under 21 CFR 10.25(a) and 
10.30 to FDA. Sidmak requested that the agency determine whether 
disulfiram tablets were withdrawn from the market for reasons other 
than safety or effectiveness. Disulfiram 250- and 500-mg tablets are 
the subject of approved NDA 7-883, formerly held by Wyeth Ayerst under 
the tradename Antabuse. In its petition, Sidmak stated that it acquired 
all rights to NDA 7-883 from Wyeth Ayerst in December 2000 and that 
``concurrent with negotiations for this sale, Wyeth Ayerst discontinued 
the marketing of its disulfiram product.''
    FDA has reviewed its records and, under Sec. 314.161, has 
determined that disulfiram 250- and 500-mg tablets approved under NDA 
7-883 were not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the agency will maintain the listing for 
these products in the ``Discontinued Drug Product List'' section of the 
Orange Book. The ``Discontinued Drug Product List'' identifies, among 
other items, drug products that have been discontinued from marketing 
for reasons other than safety or effectiveness. The approval status of 
the approved ANDAs that refer to disulfiram 250- and 500-mg tablets is 
unaffected. Additional ANDAs for dilsulfiram 250- and 500-mg tablets 
may also be approved by the agency.

    Dated: September 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-24039 Filed 9-25-01; 8:45 am]
BILLING CODE 4160-01-S