82 FR 46070 - Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46070-46071 | |
| FR Document | 2017-21174 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46070-46071] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21174] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-2530] Determination That SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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and Drug Administration (FDA or Agency) has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness.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: Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455. 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, a drug is 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. SPECTAZOLE (econazole nitrate) topical cream, 1%, is the subject of NDA 018751, held by Alvogen Malta Operations Ltd., and initially approved on December 23, 1982. SPECTAZOLE is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum; in the treatment of cutaneous candidiasis; and in the treatment of tinea versicolor. SPECTAZOLE (econazole nitrate) topical cream, 1%, is currently listed in [[Page 46071]] the ``Discontinued Drug Product List'' section of the Orange Book. Lachman Consultant Services, Inc. submitted a citizen petition dated April 21, 2017 (Docket No. FDA-2017-P-2530), under 21 CFR 10.30, requesting that the Agency determine whether SPECTAZOLE (econazole nitrate) topical cream, 1%, 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 SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that SPECTAZOLE (econazole nitrate) topical cream, 1%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of SPECTAZOLE (econazole nitrate) topical cream, 1%, 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 SPECTAZOLE (econazole nitrate) topical cream, 1%, 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: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21174 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
![46070 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
FOR FURTHER INFORMATION CONTACT: III. Nomination Procedures Ave., Bldg. 51, Rm. 6222, Silver Spring,
Regarding all nomination questions for Any interested person may nominate MD 20993–0002, 301–796–4455.
membership: Caryn Cohen, Office of one or more qualified individuals for SUPPLEMENTARY INFORMATION: In 1984,
Science, Center for Tobacco Products, membership on the advisory committee. Congress enacted the Drug Price
Food and Drug Administration, Center Self-nominations are also accepted. Competition and Patent Term
for Tobacco Products, Document Nominations must include a current, Restoration Act of 1984 (Pub. L. 98–417)
Control Center, Building 71, Rm. G335, complete résumé or curriculum vitae for (the 1984 amendments), which
10903 New Hampshire Ave., Silver each nominee and a signed copy of the authorized the approval of duplicate
Spring, MD 20993–0002, 1–877–287– Acknowledgement and Consent form versions of drug products under an
1373 (choose Option 5), TPSAC@ available at the FDA Advisory ANDA procedure. ANDA applicants
fda.hhs.gov. Nomination Portal (see ADDRESSES). must, with certain exceptions, show that
Information about becoming a Nominations must also specify the the drug for which they are seeking
member on an FDA advisory committee advisory committee for which the approval contains the same active
can also be obtained by visiting FDA’s nominee is recommended. Nominations ingredient in the same strength and
Web site by using the following link: must also acknowledge that the dosage form as the listed drug, which is
https://www.fda.gov/ nominee is aware of the nomination a version of the drug that was
AdvisoryCommittees/default.htm. unless self-nominated. FDA will ask previously approved. ANDA applicants
potential candidates to provide detailed do not have to repeat the extensive
SUPPLEMENTARY INFORMATION: FDA is clinical testing otherwise necessary to
information concerning such matters
requesting nomination for voting gain approval of a new drug application
related to financial holdings,
members on the Tobacco Products (NDA).
employment, and research grants and/or
Scientific Advisory Committee. The 1984 amendments include what
contracts to permit evaluation of
I. General Description of the Committee possible sources of conflicts of interest. is now section 505(j)(7) of the Federal
Duties This notice is issued under the Food, Drug, and Cosmetic Act (21 U.S.C.
Federal Advisory Committee Act (5 355(j)(7)), which requires FDA to
The Tobacco Products Scientific U.S.C. app. 2) and 21 CFR part 14, publish a list of all approved drugs.
Advisory Committee (the Committee) relating to advisory committees. FDA publishes this list as part of the
advises the Commissioner of Food and ‘‘Approved Drug Products with
Dated: September 27, 2017.
Drugs (the Commissioner) or designee in Therapeutic Equivalence Evaluations,’’
discharging responsibilities related to Anna K. Abram,
which is known generally as the Orange
the regulation of tobacco products. The Deputy Commissioner for Policy, Planning,
Book. Under FDA regulations, a drug is
Committee reviews and evaluates safety, Legislation, and Analysis.
removed from the list if the Agency
dependence, and health issues relating [FR Doc. 2017–21173 Filed 10–2–17; 8:45 am]
withdraws or suspends approval of the
to tobacco products and provides BILLING CODE 4164–01–P
drug’s NDA or ANDA for reasons of
appropriate advice, information, and safety or effectiveness or if FDA
recommendations to the Commissioner. determines that the listed drug was
DEPARTMENT OF HEALTH AND
II. Criteria for Voting Members withdrawn from sale for reasons of
HUMAN SERVICES
safety or effectiveness (21 CFR 314.162).
The Committee consists of 12 Food and Drug Administration A person may petition the Agency to
members including the Chair. Members determine, or the Agency may
and the Chair are selected by the [Docket No. FDA–2017–P–2530] determine on its own initiative, whether
Commissioner or designee from among a listed drug was withdrawn from sale
Determination That SPECTAZOLE
individuals knowledgeable in the fields for reasons of safety or effectiveness.
(Econazole Nitrate) Topical Cream, 1%,
of medicine, medical ethics, science, or This determination may be made at any
Was Not Withdrawn From Sale for
technology involving the manufacture, time after the drug has been withdrawn
Reasons of Safety or Effectiveness
evaluation, or use of tobacco products. from sale, but must be made prior to
Almost all non-Federal members of this AGENCY: Food and Drug Administration, approving an ANDA that refers to the
committee serve as Special Government HHS. listed drug (§ 314.161 (21 CFR 314.161)).
Employees. The Committee includes ACTION: Notice. FDA may not approve an ANDA that
nine technically qualified voting does not refer to a listed drug.
members, selected by the Commissioner SUMMARY: The Food and Drug SPECTAZOLE (econazole nitrate)
or designee. The nine voting members Administration (FDA or Agency) has topical cream, 1%, is the subject of NDA
include seven members who are determined that SPECTAZOLE 018751, held by Alvogen Malta
physicians, dentists, scientists, or health (econazole nitrate) topical cream, 1%, Operations Ltd., and initially approved
care professionals practicing in the area was not withdrawn from sale for reasons on December 23, 1982. SPECTAZOLE is
of oncology, pulmonology, cardiology, of safety or effectiveness. This indicated for topical application in the
toxicology, pharmacology, addiction, or determination means that FDA will not treatment of tinea pedis, tinea cruris,
any other relevant specialty. The nine begin procedures to withdraw approval and tinea corporis caused by
voting members also include one of abbreviated new drug applications Trichophyton rubrum, Trichophyton
(ANDAs) that refer to this drug product,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
member who is an officer or employee mentagrophytes, Trichophyton
of a State or local government or of the and it will allow FDA to continue to tonsurans, Microsporum canis,
Federal Government, and one member approve ANDAs that refer to the Microsporum audouini, Microsporum
who is a representative of the general product as long as they meet relevant gypseum, and Epidermophyton
public. Almost all non-Federal members legal and regulatory requirements. floccosum; in the treatment of
of this committee serve as Special FOR FURTHER INFORMATION CONTACT: cutaneous candidiasis; and in the
Government Employees. Members will Nisha Shah, Center for Drug Evaluation treatment of tinea versicolor.
be invited to serve for terms of up to 4 and Research, Food and Drug SPECTAZOLE (econazole nitrate)
years. Administration, 10903 New Hampshire topical cream, 1%, is currently listed in
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46071
the ‘‘Discontinued Drug Product List’’ DEPARTMENT OF HEALTH AND confidential information that you or a
section of the Orange Book. HUMAN SERVICES third party may not wish to be posted,
Lachman Consultant Services, Inc. such as medical information, your or
Food and Drug Administration anyone else’s Social Security number, or
submitted a citizen petition dated April
[Docket No. FDA–2017–D–5739] confidential business information, such
21, 2017 (Docket No. FDA–2017–P–
as a manufacturing process. Please note
2530), under 21 CFR 10.30, requesting
Formal Meetings Between the Food that if you include your name, contact
that the Agency determine whether information, or other information that
and Drug Administration and
SPECTAZOLE (econazole nitrate) identifies you in the body of your
Abbreviated New Drug Application
topical cream, 1%, was withdrawn from comments, that information will be
Applicants of Complex Products Under
sale for reasons of safety or Generic Drug User Fee Act; Draft posted on https://www.regulations.gov.
effectiveness. Guidance for Industry; Availability • If you want to submit a comment
After considering the citizen petition with confidential information that you
AGENCY: Food and Drug Administration, do not wish to be made available to the
and reviewing Agency records and
HHS. public, submit the comment as a
based on the information we have at this
time, FDA has determined under ACTION: Notice of availability. written/paper submission and in the
§ 314.161 that SPECTAZOLE (econazole manner detailed (see ‘‘Written/Paper
SUMMARY: The Food and Drug
nitrate) topical cream, 1%, was not Submissions’’ and ‘‘Instructions’’).
Administration (FDA or Agency) is
withdrawn for reasons of safety or announcing the availability of a draft Written/Paper Submissions
effectiveness. The petitioner has guidance for industry entitled ‘‘Formal Submit written/paper submissions as
identified no data or other information Meetings Between FDA and ANDA follows:
suggesting that SPECTAZOLE Applicants of Complex Products Under • Mail/Hand delivery/Courier (for
(econazole nitrate) topical cream, 1%, GDUFA.’’ This draft guidance describes written/paper submissions): Dockets
was withdrawn for reasons of safety or an enhanced pathway for discussions Management Staff (HFA–305), Food and
effectiveness. We have carefully between FDA and a prospective Drug Administration, 5630 Fishers
reviewed our files for records applicant preparing to submit (or an Lane, Rm. 1061, Rockville, MD 20852.
concerning the withdrawal of applicant that has submitted) to FDA an • For written/paper comments
SPECTAZOLE (econazole nitrate) abbreviated new drug application submitted to Dockets Management Staff,
topical cream, 1%, from sale. We have (ANDA) for a complex product. FDA will post your comment, as well as
also independently evaluated relevant Specifically, this draft guidance any attachments, except for information
provides information on requesting and submitted, marked and identified, as
literature and data for possible
conducting product development confidential, if submitted as detailed in
postmarketing adverse events. We have
meetings, pre-submission meetings, and ‘‘Instructions.’’
reviewed the available evidence and mid-review-cycle meetings with FDA. Instructions: All submissions received
determined that this drug product was This draft guidance will assist must include the Docket No. FDA–
not withdrawn from sale for reasons of applicants in generating and submitting 2017–D–5739 for ‘‘Formal Meetings
safety or effectiveness. a meeting request and the associated Between FDA and ANDA Applicants of
Accordingly, the Agency will meeting package to FDA for complex Complex Products Under GDUFA; Draft
continue to list SPECTAZOLE products to be submitted under the Guidance for Industry; Availability.’’
(econazole nitrate) topical cream, 1%, in Federal Food, Drug, and Cosmetic Act Received comments will be placed in
the ‘‘Discontinued Drug Product List’’ (FD&C Act) and as contemplated in the the docket and, except for those
section of the Orange Book. The commitments made by FDA in submitted as ‘‘Confidential
‘‘Discontinued Drug Product List’’ connection with the reauthorization of Submissions,’’ publicly viewable at
delineates, among other items, drug the Generic Drug User Fee Amendments https://www.regulations.gov or at the
products that have been discontinued for Fiscal Years (FYs) 2018–2022 Dockets Management Staff between 9
from marketing for reasons other than (GDUFA II). a.m. and 4 p.m., Monday through
safety or effectiveness. FDA will not DATES: Submit either electronic or Friday.
written comments on the draft guidance • Confidential Submissions—To
begin procedures to withdraw approval
by December 4, 2017 to ensure that the submit a comment with confidential
of approved ANDAs that refer to this
Agency considers your comment on this information that you do not wish to be
drug product. Additional ANDAs for
draft guidance before it begins work on made publicly available, submit your
this drug product may also be approved comments only as a written/paper
the final version of the guidance.
by the Agency as long as they meet all submission. You should submit two
ADDRESSES: You may submit comments
other legal and regulatory requirements copies total. One copy will include the
for the approval of ANDAs. If FDA on any guidance at any time as follows:
information you claim to be confidential
determines that labeling for this drug Electronic Submissions with a heading or cover note that states
product should be revised to meet Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS
current standards, the Agency will following way: CONFIDENTIAL INFORMATION.’’ The
advise ANDA applicants to submit such • Federal eRulemaking Portal: Agency will review this copy, including
labeling.
asabaliauskas on DSKBBXCHB2PROD with NOTICES
https://www.regulations.gov. Follow the the claimed confidential information, in
Dated: September 27, 2017. instructions for submitting comments. its consideration of comments. The
Anna K. Abram,
Comments submitted electronically, second copy, which will have the
including attachments, to https:// claimed confidential information
Deputy Commissioner for Policy, Planning, www.regulations.gov will be posted to redacted/blacked out, will be available
Legislation, and Analysis.
the docket unchanged. Because your for public viewing and posted on
[FR Doc. 2017–21174 Filed 10–2–17; 8:45 am] comment will be made public, you are https://www.regulations.gov. Submit
BILLING CODE 4164–01–P solely responsible for ensuring that your both copies to the Dockets Management
comment does not include any Staff. If you do not wish your name and
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Document Created: 2017-10-03 01:01:21
Document Modified: 2017-10-03 01:01:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Nisha Shah, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455. | |
| FR Citation | 82 FR 46070 |
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