41624 Federal Register / Vol. 82, No. 169 / Friday, September 1, 2017 / Notices 

owners, suppliers, and employees, as 

well as recommendations on how to 

ensure that disadvantaged communities 

are not denied the wide range of 

opportunities made possible by nextgeneration networks. This agenda may 

be modified at the discretion of the 

ACDDE Chair and the DFO. 

Federal Communications Commission. 

Thomas Horan, 

Chief of Staff, Media Bureau. 

[FR Doc. 2017–18550 Filed 8–31–17; 8:45 am] 

BILLING CODE 6712–01–P 

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Were Not Withdrawn From Sale for 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. 

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(mg), were not withdrawn from sale for 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 (§ 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 

§ 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4302] 

Electronic Study Data Submission; 

Data Standards; Support End Date for 

Study Data Tabulation Model Version 

1.2, Implementation Guide Version 

3.1.2, and Implementation Guide 

Version 3.1.2, Amendment 1 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Biologics Evaluation and 

Research (CBER) and Center for Drug 

Evaluation and Research (CDER) are 

announcing the end of support for 

Version 1.2 of Clinical Data Interchange 

Standards Consortium Study Data 

Tabulation Model (SDTM) and an 


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