[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Page 41624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18548]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5079]


Determination That NIZORAL (Ketoconazole) Tablets, 200 
Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or 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 or Agency) has 
determined that NIZORAL (ketoconazole) tablets, 200 milligrams (mg), 
were not withdrawn from sale for reasons of safety or effectiveness.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 
NIZORAL, and it will allow FDA to continue to approve ANDAs that 
reference NIZORAL as long as they meet relevant legal and regulatory 
requirements.

FOR FURTHER INFORMATION CONTACT: Robin Fastenau, Center for Drug 
Evaluation Research, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 240-402-4510.

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) tablets, 200 mg, is the subject of NDA 018-
533 and was originally held by Johnson & Johnson Research and 
Development, L.L.C., now known as Janssen Research & Development, 
L.L.C. (Janssen). It was initially approved on June 12, 1981. NIZORAL 
should be used only when other effective antifungal therapy is not 
available or tolerated and the potential benefits are considered to 
outweigh the potential risks. NIZORAL is indicated for the treatment of 
the following systemic fungal infections in patients who have failed or 
who are intolerant to other therapies: blastomycosis, 
coccidioidomycosis, histoplasmosis, chromomycosis, and 
paracoccidioidomycosis.
    In a letter dated May 22, 2008, Janssen, which at that time was 
operating as Johnson & Johnson Pharmaceutical Research & Development, 
L.L.C., acting on behalf of Ortho-McNeil-Janssen Pharmaceuticals, Inc., 
notified FDA that NIZORAL (ketoconazole) tablets, 200 mg, were being 
discontinued and requested withdrawal of NDA 018-533. In the Federal 
Register of October 13, 2015 (80 FR 61426), FDA announced that it was 
withdrawing approval of NDA 018-533, effective November 12, 2015.
    After reviewing Agency records and based on the information we have 
at this time, FDA has determined under Sec.  314.161 that NIZORAL 
(ketoconazole) tablets, 200 mg, were not withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of NIZORAL (ketoconazole) tablets, 
200 mg, from sale. We have also independently evaluated relevant 
literature and data for possible postmarketing adverse events. We have 
reviewed the available evidence and determined that this drug product 
was not withdrawn from sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list NIZORAL 
(ketoconazole) tablets, 200 mg, 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 NIZORAL. Additional ANDAs that refer to 
NIZORAL (ketoconazole) tablets, 200 mg, 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: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18548 Filed 8-31-17; 8:45 am]
 BILLING CODE 4164-01-P