[Federal Register Volume 72, Number 57 (Monday, March 26, 2007)]
[Notices]
[Page 14118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5415]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0255]


Determination That DURICEF (Cefadroxil USP) Tablets, 1 Gram, and 
Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of 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 
DURICEF (cefadroxil USP) Tablets, 1 gram (g), and Capsules, 500 
milligrams (mg), were not withdrawn from sale for reasons of safety or 
effectiveness. This determination will allow FDA to continue to approve 
abbreviated new drug applications (ANDAs) for cefadroxil USP tablets, 1 
g, and cefadroxil USP capsules, 500 mg.

FOR FURTHER INFORMATION CONTACT: Mary Catchings, 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 enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 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 
typically a version of the drug that was previously approved. 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.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetics 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,'' 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 Under FDA regulations, drugs are withdrawn from the list if the 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 withdrawn from sale for reasons of safety or 
effectiveness (21 CFR 314.162).
    Under 21 CFR 314.161(a), the circumstances under which the agency 
must determine whether a listed drug was withdrawn from sale for 
reasons of safety or effectiveness include: (1) Before an ANDA that 
refers to that listed drug may be approved and (2) whenever a listed 
drug is voluntarily withdrawn from sale, and ANDAs that refer to the 
listed drug have been approved. Section 314.161(d) provides that if FDA 
determines that a listed drug was withdrawn from sale for safety or 
effectiveness reasons, the agency will initiate proceedings that could 
result in the withdrawal of approval of the ANDAs that refer to the 
listed drug. FDA may not approve an ANDA that does not refer to a 
listed drug.
    DURICEF (cefadroxil USP) Tablets, 1 g, and Capsules, 500 mg, are 
the subjects of approved NDA 50-528 and NDA 50-512, respectively, held 
by Warner Chilcott, Inc. (Warner Chilcott). DURICEF is an antibiotic 
indicated to treat infections of the urinary tract, skin, throat, and 
tonsils, caused by specific bacteria, including streptococci, 
staphylococci, and Escherichia coli. Warner Chilcott has informed FDA 
that DURICEF (cefadroxil USP) Tablets 1 g, and Capsules, 500 mg, have 
been withdrawn from sale.
    In a citizen petition dated June 13, 2006 (Docket No. 2006P-0255/
CP1), submitted under 21 CFR 10.30, Orchid Healthcare (a division of 
Orchid Chemicals & Pharmaceuticals Ltd.) requested that the agency 
determine whether DURICEF (cefadroxil USP) Tablets, 1 g, were withdrawn 
from sale for reasons of safety or effectiveness. In addition, there 
are approved ANDAs that refer to DURICEF (cefadroxil USP) Tablets, 1 g, 
and Capsules, 500 mg.
    The agency has determined that Warner Chilcott's DURICEF 
(cefadroxil USP) Tablets, 1 g, and Capsules, 500 mg, were not withdrawn 
from sale for reasons of safety or effectiveness. The petitioner 
identified no data or other information suggesting that DURICEF 
Tablets, 1 g, and Capsules, 500 mg, were withdrawn from sale for 
reasons of safety or effectiveness. FDA has independently evaluated 
relevant literature and data for possible postmarketing adverse events 
and has found no information that would indicate that either DURICEF 
Tablets, 1 g, or Capsules, 500 mg, were withdrawn from sale for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that, for the reasons outlined in this 
document, DURICEF (cefadroxil USP) Tablets, 1 g, and Capsules, 500 mg, 
were not withdrawn from sale for reasons of safety or effectiveness. 
Accordingly, the agency will continue to list DURICEF (cefadroxil USP) 
Tablets, 1 g, and Capsules, 500 mg, in the ``Discontinued Drug Product 
List'' section of the Orange Book. The ``Discontinued Drug Product 
List'' delineates, among other items, drug products that have been 
discontinued from marketing for reasons other than safety or 
effectiveness. Approved ANDAs that refer to DURICEF cefadroxil USP) 
Tablets, 1 g, and Capsules, 500 mg, are unaffected by the withdrawal of 
these products from sale. ANDAs that refer to cefadroxil USP (tablets, 
1 g, and cefadroxil USP capsules, 500 mg, may be approved by the agency 
as long as they meet all relevant legal and regulatory requirements for 
the approval of ANDAs.

    Dated: March 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-5415 Filed 3-23-07; 8:45 am]
BILLING CODE 4160-01-S