[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Pages 27135-27136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-4812]


Determination That NIZORAL (Ketoconazole) Topical Cream, 2%, 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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, Agency, or we) has 
determined that NIZORAL (ketoconazole) topical cream, 2%, 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withdrawn from sale for reasons of safety or effectiveness.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: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

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.
    NIZORAL (ketoconazole) topical cream, 2%, is the subject of NDA 
019084, previously held by Johnson & Johnson Pharmaceutical Research 
and Development, LLC and initially approved on December 31, 1985. 
NIZORAL is indicated for the topical treatment of tinea corporis, tinea 
cruris, and tinea pedis caused by Trichophyton rubrum, T. 
mentagrophytes, and Epidermophyton floccosum; of tinea (pityriasis) 
versicolor caused by Malassezia furfur (Pityrosporum orbiculare); of 
cutaneous candidiasis caused by Candida spp.; and of seborrheic 
dermatitis.

[[Page 27136]]

    In a letter dated August 25, 2004, Johnson & Johnson Pharmaceutical 
Research and Development, LLC requested withdrawal of NDA 019084 for 
NIZORAL (ketoconazole) topical cream, 2%. In the Federal Register of 
November 7, 2007 (72 FR 62858), FDA announced that it was withdrawing 
approval of NDA 019084, effective December 7, 2007.
    Arent Fox LLP submitted a citizen petition dated December 19, 2018 
(Docket No. FDA-2018-P-4812), under 21 CFR 10.30, requesting that the 
Agency determine whether NIZORAL (ketoconazole) topical cream, 2%, 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 NIZORAL (ketoconazole) topical cream, 2%, was 
not withdrawn for reasons of safety or effectiveness. The petitioner 
has identified no data or other information suggesting that NIZORAL 
(ketoconazole) topical cream, 2%, was withdrawn for reasons of safety 
or effectiveness. We have carefully reviewed our files for records 
concerning the withdrawal of NIZORAL (ketoconazole) topical cream, 2%, 
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 NIZORAL 
(ketoconazole) topical cream, 2%, 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 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12308 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P


