[Federal Register: March 26, 2007 (Volume 72, Number 57)]
[Notices]
[Page 14118]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr07-61]
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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Capsules, 500 Milligrams, Were Not Withdrawn From Sale for Reasons of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milligrams (mg), were not withdrawn from sale for reasons of safety or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 Under FDA regulations, drugs are withdrawn from the list if the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