E7-10959. 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That CEFOTAN (Cefotetan Disodium For Injection), Equivalent 1 Gram Base/Vial and 2 Grams Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness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.

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determined that CEFOTAN (cefotetan disodium for injection), equivalent 1 gram (g) base/vial and 2 g base/vial, was not withdrawn from sale for reasons of safety or effectiveness.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,” 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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under 21 CFR 314.161(a)(1), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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.