[Federal Register Volume 72, Number 109 (Thursday, June 7, 2007)]
[Notices]
[Pages 31585-31586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10959]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006P-0201]


Determination That CEFOTAN (Cefotetan Disodium For Injection), 
Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, Was Not Withdrawn 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 
CEFOTAN (cefotetan disodium for injection), equivalent 1 gram (g) base/
vial and 2 g base/vial, was not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for cefotetan disodium for 
injection, equivalent 1 g base/vial and 2 g base/vial, if all other 
legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research (HFD-7), Food and Drug Administration, 5515 Security Lane, 
Rockville, MD 20852, 301-443-5537.

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,''

[[Page 31586]]

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 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,'' 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)(1), the agency must determine whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/
vial and 2 g base/vial, is the subject of approved NDA 50-588 held by 
AstraZeneca Pharmaceuticals LP (AstraZeneca). CEFOTAN (cefotetan 
disodium for injection) is indicated for the therapeutic treatment of 
urinary tract infections, lower respiratory tract infections, skin and 
skin structure infections, gynecologic infections, intra-abdominal 
infections, and bone and joint infections when caused by susceptible 
strains of the designated organisms described in the labeling. FDA 
approved the NDA for CEFOTAN (cefotetan disodium for injection), 
equivalent 1 g base/vial and 2 g base/vial, on December 27, 1985. 
Beginning with the October 2006 update, FDA has listed CEFOTAN 
(cefotetan disodium for injection), equivalent 1 g base/vial and 2 g 
base/vial, in the ``Discontinued Drug Product List'' of the Orange Book 
because AstraZeneca notified FDA that the product was no longer 
marketed.
    B. Braun Medical Inc., submitted a citizen petition dated May 10, 
2006 (Docket No. 2006P-0201/CP1), under 21 CFR 10.30, requesting that 
the agency determine whether CEFOTAN (cefotetan disodium for 
injection), equivalent 1 g base/vial and 2 g base/vial (NDA 50-588) was 
withdrawn from sale for reasons of safety or effectiveness. After 
considering the citizen petition (including comments submitted) and 
reviewing agency records, FDA has determined that CEFOTAN (cefotetan 
disodium for injection), equivalent 1 g base/vial and 2 g base/vial, 
was not withdrawn from sale for reasons of safety or effectiveness. The 
petitioner identified no data or other information suggesting that 
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial 
and 2 g base/vial, was withdrawn from sale as a result of safety or 
effectiveness concerns. FDA has independently evaluated relevant 
literature and data for adverse event reports and has found no 
information that would indicate that CEFOTAN (cefotetan disodium for 
injection), equivalent 1 g base/vial and 2 g base/vial, was withdrawn 
for reasons of safety or effectiveness.
    For the reasons outlined in this document, FDA determines that 
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial 
and 2 g base/vial, was not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the agency will continue to list CEFOTAN 
(cefotetan disodium for injection), equivalent 1 g base/vial and 2 g 
base/vial, 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. ANDAs that refer to 
CEFOTAN (cefotetan disodium for injection), equivalent 1 g base/vial 
and 2 g base/vial, may be approved by the agency as long as they meet 
all relevant legal and regulatory requirements for approval of ANDAs. 
If FDA determines that labeling for these drug products should be 
revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.

    Dated: May 31, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10959 Filed 6-6-07; 8:45 am]
BILLING CODE 4160-01-S