Document ID: FDA-2013-P-0768-0004
Agency: fda
Document Type: Notice
Title: Determination That ZEFAZONE (Cefmetazole Sodium) Injection,
Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and
ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20
Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or
Effectiveness
Posted Date: 2014-03-10T04:00Z

[Federal Register Volume 79, Number 46 (Monday, March 10, 2014)]
[Notices]
[Pages 13307-13308]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05059]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0768]

Determination That ZEFAZONE (Cefmetazole Sodium) Injection, 
Equivalent to 1 Gram Base/Vial and Equivalent to 2 Gram Base/Vial, and 
ZEFAZONE (Cefmetazole Sodium) Intravenous Solution, Equivalent to 20 
Milligrams Base/Milliliter and Equivalent to 40 Milligrams Base/
Milliliter, Were Not Withdrawn From Sale for Reasons of Safety or 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 
ZEFAZONE (cefmetazole sodium) Injection, equivalent to (EQ) 1 gram (g) 
base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) 
Intravenous (IV) Solution, EQ 20 milligrams (mg) base/milliliter (mL) 
and EQ 40 mg base/mL, were not withdrawn from sale for reasons of 
safety or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for ZEFAZONE (cefmetazole 
sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE 
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and 40 mg base/mL, 
if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Kathy Schreier, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993-0002, 301-
796-3432.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
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 version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    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 known generally as the Orange Book. 
Under FDA regulations, drugs are removed 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).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 
g base/vial, is the subject of NDA 50-637, held by Pharmacia & Upjohn, 
Inc., which was initially approved on December 11, 1989; and ZEFAZONE 
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, is the subject of NDA 50-683, held by Pharmacia & Upjohn, Inc., 
which was initially approved on December 29, 1992. ZEFAZONE is a 
semisynthetic cephem antibiotic that is indicated for treatment of 
urinary tract infections, lower respiratory tract infections, skin and 
skin structure infections, and intra-abdominal infections.
    In a letter dated August 1, 2000, Pharmacia & Upjohn, Inc., 
notified FDA that ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/
vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) IV 
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, were no longer being 
marketed and requested withdrawal of NDA 50-637 and NDA 50-683. FDA 
moved the drug products to the ``Discontinued Drug Product List'' 
section of the Orange Book and, in the Federal Register of August 16, 
2001 (66 FR 43017), announced that it was withdrawing approval of NDA 
50-637 and NDA 50-683 effective September 17, 2001.
    Salus Pharma LLC submitted a citizen petition dated June 17, 2013 
(Docket No. FDA-2013-P-0768), under 21 CFR 10.30, requesting that the 
Agency determine whether ZEFAZONE (cefmetazole sodium) Injection, EQ 1 
g base/vial and EQ 2 g base/vial, was withdrawn from sale for reasons 
of safety or effectiveness. Although the citizen petition did not 
request that we determine whether ZEFAZONE (cefmetazole sodium) IV 
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, approved under NDA 50-
683, was withdrawn for safety or effectiveness, that product also has 
been discontinued. On our own initiative, we have also determined 
whether ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and 
EQ 40 mg base/mL, was withdrawn for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records 
and based on the information we have at this time, FDA has determined 
under Sec.  314.161 that ZEFAZONE (cefmetazole sodium) Injection, EQ 1 
g base/vial and EQ 2 g base/vial, and ZEFAZONE (cefmetazole sodium) IV 
Solution, EQ 20 mg base/mL and EQ 40 mg base/mL, were not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that ZEFAZONE (cefmetazole sodium) 
Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE 
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, were withdrawn for reasons of safety or effectiveness. We have 
carefully reviewed our files for records concerning the withdrawal of 
ZEFAZONE (cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g 
base/vial, and ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg 
base/mL and EQ 40 mg base/mL, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
these products were withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list ZEFAZONE (cefmetazole 
sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, and ZEFAZONE 
(cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 40 mg base/
mL, 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

[[Page 13308]]

other than safety or effectiveness. ANDAs that refer to ZEFAZONE 
(cefmetazole sodium) Injection, EQ 1 g base/vial and EQ 2 g base/vial, 
and ZEFAZONE (cefmetazole sodium) IV Solution, EQ 20 mg base/mL and EQ 
40 mg base/mL, may be approved by the Agency as long as they meet all 
other legal and regulatory requirements for the 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: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05059 Filed 3-7-14; 8:45 am]
BILLING CODE 4160-01-P