[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31873-31874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14172]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-1366]


Determination That CLAFORAN (Cefotaxime Sodium) for Injection, 
500 Milligrams/Vial, 1 Gram/Vial, 2 Grams/Vial and 10 Grams/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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 or Agency) has 
determined that CLAFORAN (cefotaxime sodium) for injection, 500 
milligrams (mg)/vial, 1 gram (g)/vial, 2 g/vial and 10 g/vial, was not 
withdrawn from sale for reasons of safety or effectiveness. This 
determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Beth Holck, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002, 240-402-7133.

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.
    CLAFORAN (cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 
2 g/vial and 10 g/vial, is the subject of NDA 050547, held by US 
Pharmaceutical Holdings II LLC, and initially approved on March 11, 
1981. CLAFORAN is indicated for the treatment of patients with serious 
bacterial infections in eight different organ systems caused by 
susceptible strains of microorganisms, as specified in the labeling.
    In a letter dated February 9, 2018, US Pharmaceutical Holdings II 
LLC notified FDA that CLAFORAN (cefotaxime for injection) 500 mg/vial, 
1 g/vial, 2 g/vial and 10 g/vial was being discontinued, and FDA moved 
the drug product to the ``Discontinued Drug Product List'' section of 
the Orange Book.

[[Page 31874]]

    Cardinal Health Regulatory Sciences submitted a citizen petition 
dated January 31, 2019 (Docket No. FDA-2019-P-1366), under 21 CFR 
10.30, requesting that the Agency determine whether CLAFORAN 
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 
10 g/vial, was withdrawn from sale 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 CLAFORAN (cefotaxime sodium) for injection, 
500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was not withdrawn for 
reasons of safety or effectiveness. The petitioner has identified no 
data or other information suggesting that CLAFORAN (cefotaxime sodium) 
for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/vial was 
withdrawn for reasons of safety or effectiveness. We have carefully 
reviewed our files for records concerning the withdrawal of CLAFORAN 
(cefotaxime sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 
10 g/vial 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 this drug product was 
withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list CLAFORAN (cefotaxime 
sodium) for injection, 500 mg/vial, 1 g/vial, 2 g/vial and 10 g/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. FDA will not begin procedures to 
withdraw approval of approved ANDAs that refer to this drug product. 
Additional ANDAs for this drug product may also 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 this 
drug product should be revised to meet current standards, the Agency 
will advise ANDA applicants to submit such labeling.

    Dated: June 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14172 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P