Determination That LOTRIMIN (Clotrimazole) Topical Solution, 1%, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 3796-3797 [2019-02139]
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Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Office of Regulatory
Policy, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6262, Silver Spring,
MD 20993, 301–796–3600.
SUPPLEMENTARY INFORMATION: NDA
202799 for OMONTYS (peginesatide)
Injection, 1 milligram (mg)/0.5 milliliter
(mL), 2 mg/0.5 mL, 3 mg/0.5 mL, 4 mg/
0.5 mL, 5 mg/0.5 mL, 6 mg/0.5 mL, 10
mg/mL, and 20 mg/2 mL, was received
on May 8, 2011, under section 505(b) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 355(b)). FDA
approved NDA 202799 on March 27,
2012, for treatment of anemia due to
chronic kidney disease in adult patients
on dialysis.
On February 23, 2013, Affymax, Inc.
and Takeda voluntarily recalled all lots
of OMONTYS and suspended its
marketing as a result of postmarketing
reports of serious hypersensitivity
reactions, including anaphylaxis, which
can be life-threatening or fatal.
Takeda subsequently requested that
FDA withdraw approval of NDA 202799
under 21 CFR 314.150(d) (§ 314.150(d))
and waived its opportunity for a
hearing. Accordingly, under
§ 314.150(d), approval of NDA 202799,
and all amendments and supplements
thereto, is withdrawn. Distribution of
OMONTYS (peginesatide) Injection, 1
mg/0.5 mL, 2 mg/0.5 mL, 3 mg/0.5 mL,
4 mg/0.5 mL, 5 mg/0.5 mL, 6 mg/0.5
mL, 10 mg/mL, and 20 mg/2 mL,
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
FD&C Act (21 U.S.C. 355(a) and 331(d)).
Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02146 Filed 2–12–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKBBV9HB2PROD with NOTICES
[Docket No. FDA–2018–P–3597]
Determination That LOTRIMIN
(Clotrimazole) Topical Solution, 1%,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that LOTRIMIN
SUMMARY:
VerDate Sep<11>2014
17:22 Feb 12, 2019
Jkt 247001
(clotrimazole) topical solution, 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not withdrawn from sale for reasons of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:
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
LOTRIMIN (clotrimazole) topical
solution, 1%, is the subject of NDA
017613, held by Schering-Plough
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Healthcare Products Inc., and initially
approved on February 3, 1975.
LOTRIMIN is indicated for the topical
treatment of candidiasis due to Candida
albicans and tinea versicolor due to
Malassezia furfur.
LOTRIMIN (clotrimazole) topical
solution, 1%, is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. In a letter
dated August 31, 2005, Schering
Corporation requested withdrawal of
NDA 017613 for LOTRIMIN
(clotrimazole). In the Federal Register of
November 7, 2007 (72 FR 62858), FDA
announced that it was withdrawing
approval of NDA 017613, effective
December 7, 2007.
Arent Fox LLP submitted a citizen
petition dated September 21, 2018
(Docket No. FDA–2018–P–3597), under
21 CFR 10.30, requesting that the
Agency determine whether LOTRIMIN
(clotrimazole) topical solution, 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
§ 314.161 that LOTRIMIN (clotrimazole)
topical solution, 1%, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that LOTRIMIN
(clotrimazole) topical solution, 1%, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
LOTRIMIN (clotrimazole) topical
solution, 1%, 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 LOTRIMIN
(clotrimazole) topical solution, 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. In addition, FDA will
continue to approve ANDAs for this
drug product as long as they meet all
other legal and regulatory requirements
for the approval of ANDAs. If the
Agency determines that labeling for this
drug product should be revised to meet
E:\FR\FM\13FEN1.SGM
13FEN1
Federal Register / Vol. 84, No. 30 / Wednesday, February 13, 2019 / Notices
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02139 Filed 2–12–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the National Advisory
Committee on Rural Health and Human
Services
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Secretary’s National
Advisory Committee on Rural Health
and Human Services (NACRHHS) has
scheduled a public meeting. Information
about NACRHHS and the agenda for this
meeting can be found on the NACRHHS
website at https://www.hrsa.gov/
advisory-committees/rural-health/
index.html.
DATES:
April 3, 2019, 8:30 a.m.–5:15 p.m.
Pacific Time (PT).
April 4, 2019, 8:30 a.m.–5:15 p.m. PT.
April 5, 2019, 8:30 a.m.–11:15 a.m.
PT.
ADDRESSES: The meeting will be held in
person. On April 3, the meeting will be
held at The Residence Inn, Sacramento
Downtown, 1121 15th Street,
Sacramento, California 95814.
On the morning of April 4, NACRHHS
will break into subcommittees. One
subcommittee will travel to Northern
Valley Indian Health Clinic, 207 N Butte
St., Willows, California 95988. The
other subcommittee will travel to Sierra
Nevada Memorial Hospital, 155 Glasson
Way, Grass Valley, California 95945. In
the afternoon at approximately 4:00
p.m. PT, NACRHHS will reconvene at
The Residence Inn, Sacramento
Downtown, 1121 15th Street,
Sacramento, California 95814.
On April 5, the meeting will be held
at The Residence Inn, Sacramento
Downtown, 1121 15th Street,
Sacramento, California 95814.
FOR FURTHER INFORMATION CONTACT:
Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, 17W59D, Rockville,
Maryland 20857; 301–443–7322; or
shirsch@hrsa.gov.
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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17:22 Feb 12, 2019
Jkt 247001
SUPPLEMENTARY INFORMATION:
NACRHHS provides advice and
recommendations to the Secretary of
HHS on policy, program development,
and other matters of significance
concerning both rural health and rural
human services.
During the April 2019 meeting,
NACRHHS will discuss the issues of
Cancer Prevention and Control in Rural
America along with Supportive Services
and Caregiving for the Rural Elderly.
Agenda items are subject to change as
priorities dictate. Refer to the
NACRHHS website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meeting. Oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to NACRHHS
should be sent to Steven Hirsch, using
the contact information above at least 3
business days prior to the meeting.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Steven Hirsch at the address and
phone number listed above at least 10
business days prior to the meeting.
John R. Womack,
Acting Deputy Director, Division of the
Executive Secretariat.
[FR Doc. 2019–02207 Filed 2–12–19; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Committee on Heritable
Disorders in Newborns and Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Advisory Committee on
Heritable Disorders in Newborns and
Children (ACHDNC) has scheduled a
public meeting. Information about the
ACHDNC and the agenda for this
meeting can be found on the ACHDNC
website at https://www.hrsa.gov/
advisory-committees/heritabledisorders/.
DATES: March 22, 2019, 10:00 a.m.–3:00
p.m. ET.
ADDRESSES: This meeting will be held
via webinar. While this meeting is open
to the public, advance registration is
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
3797
required. Please visit the ACHDNC
website for information on registration:
https://www.hrsa.gov/advisorycommittees/heritable-disorders/
index.html. The deadline for online
registration is 5:00 p.m. ET on March
20, 2019. Instructions on how to access
the meeting via webinar will be
provided upon registration.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau (MCHB), HRSA, 5600
Fishers Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; or
AHarris@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACHDNC
provides advice and recommendations
to the Secretary of HHS (Secretary) on
the development of newborn screening
activities, technologies, policies,
guidelines, and programs for effectively
reducing morbidity and mortality in
newborns and children having, or at risk
for, heritable disorders. ACHDNC’s
recommendations regarding inclusion of
additional conditions for screening,
following adoption by the Secretary, are
evidence-informed preventive health
services provided for in the
comprehensive guidelines supported by
HRSA through the Recommended
Uniform Screening Panel (RUSP)
pursuant to section 2713 of the Public
Health Service Act (42 U.S.C. 300gg–
13). Under this provision, nongrandfathered group health plans and
health insurance issuers offering group
or individual health insurance are
required to provide insurance coverage
without cost-sharing (a co-payment, coinsurance, or deductible) for preventive
services for plan years (i.e., policy years)
beginning on or after the date that is one
year from the Secretary’s adoption of the
condition for screening.
During the March 2019 meeting,
ACHDNC will hear from experts in the
fields of public health, medicine,
heritable disorders, rare disorders, and
newborn screening. Tentative agenda
topics include: (1) The condition
nomination and evidence review
process, (2) rare disease registries, and
(3) implementation of conditions on the
RUSP. Agenda items are subject to
change as priorities dictate and the final
meeting agenda will be available on
ACHDNC’s website: https://
www.hrsa.gov/advisory-committees/
heritable-disorders/.
Information about ACHDNC, a roster of
members, as well as past meeting
summaries are also available on the
ACHDNC website.
Members of the public will have the
opportunity to provide comments,
which are part of the official committee
record. To submit written comments or
E:\FR\FM\13FEN1.SGM
13FEN1
]]>Agencies
[Federal Register Volume 84, Number 30 (Wednesday, February 13, 2019)]
[Notices]
[Pages 3796-3797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02139]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-P-3597]
Determination That LOTRIMIN (Clotrimazole) Topical Solution, 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 LOTRIMIN (clotrimazole) topical solution, 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: 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.
LOTRIMIN (clotrimazole) topical solution, 1%, is the subject of NDA
017613, held by Schering-Plough Healthcare Products Inc., and initially
approved on February 3, 1975. LOTRIMIN is indicated for the topical
treatment of candidiasis due to Candida albicans and tinea versicolor
due to Malassezia furfur.
LOTRIMIN (clotrimazole) topical solution, 1%, is currently listed
in the ``Discontinued Drug Product List'' section of the Orange Book.
In a letter dated August 31, 2005, Schering Corporation requested
withdrawal of NDA 017613 for LOTRIMIN (clotrimazole). In the Federal
Register of November 7, 2007 (72 FR 62858), FDA announced that it was
withdrawing approval of NDA 017613, effective December 7, 2007.
Arent Fox LLP submitted a citizen petition dated September 21, 2018
(Docket No. FDA-2018-P-3597), under 21 CFR 10.30, requesting that the
Agency determine whether LOTRIMIN (clotrimazole) topical solution, 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 LOTRIMIN (clotrimazole) topical solution, 1%,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LOTRIMIN (clotrimazole) topical solution, 1%, was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of LOTRIMIN (clotrimazole) topical
solution, 1%, 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 LOTRIMIN
(clotrimazole) topical solution, 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. In addition, FDA will
continue to approve ANDAs for this drug product as long as they meet
all other legal and regulatory requirements for the approval of ANDAs.
If the Agency determines that labeling for this drug product should be
revised to meet
[[Page 3797]]
current standards, the Agency will advise ANDA applicants to submit
such labeling.
Dated: February 8, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02139 Filed 2-12-19; 8:45 am]
BILLING CODE 4164-01-P
